NA 04.005.532Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10886982086006), received between Jan 5, 2018 and Jul 25, 2022 — classified as 23 injuries.

The most frequently reported specific device problem is “Break” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryJul 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DDRA) [SUMMARY OF RETROSPECTIVE DATA FOR PATIENTS TREATED WITH THE LATERAL FEMORAL NAIL, ADOLESCENT LATERAL FEMORAL NAIL, AND THE FEMORAL RECON NAIL]. BETWEEN JANUARY 2014 AND OCTOBER 2021, A TOTAL OF 300 PATIENTS (219 PATIENTS TREATED WITH LFN, 56 PATIENTS TREATED WITH ALFN, AND 25 PATIENTS TREATED WITH FRN) WERE INCLUDED IN THE REPORT IF THEY HAD EITHER 9 MONTHS OF FOLLOW-UP OR EVIDENCE OF HEALING. THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED IN THE BRONSON METHODIST HOSPITAL¿S ORTHOPEDIC INPATIENT DATABASE: LFN GROUP: PATIENT 5: A 32-YEAR-OLD MALE PATIENT HAD A WEAKNESS IN LEG, WHICH RESOLVED WITH PHYSICAL THERAPY. PATIENT 6: AN 81-YEAR-OLD MALE PATIENT HAD A PERSISTENT SWELLING ABOUT KNEE 1.5 YEARS POSTOPERATIVELY, COMPRESSION. PATIENT 8: A 58-YEAR-OLD FEMALE PATIENT HAD A PULMONARY EMBOLISM. PATIENT 9: A 35-YEAR-OLD FEMALE PATIENT HAD DIFFICULT REDUCTION INTRAOPERATIVELY AND HAD RESIDUAL SORENESS AT INCISION SITE POSTOPERATIVELY. PATIENT 13: A 16-YEAR-OLD MALE PATIENT HAD PAIN WITH IMPLANTS LEADING TO REHOSPITALIZATION FOR ADJUNCTIVE PLATE REMOVAL, L

  Patient problems: Fatigue

  MAUDE report 15093426 ↗
• InjuryJul 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DDRA) [SUMMARY OF RETROSPECTIVE DATA FOR PATIENTS TREATED WITH THE LATERAL FEMORAL NAIL, ADOLESCENT LATERAL FEMORAL NAIL, AND THE FEMORAL RECON NAIL]. BETWEEN JANUARY 2014 AND OCTOBER 2021, A TOTAL OF 300 PATIENTS (219 PATIENTS TREATED WITH LFN, 56 PATIENTS TREATED WITH ALFN, AND 25 PATIENTS TREATED WITH FRN) WERE INCLUDED IN THE REPORT IF THEY HAD EITHER 9 MONTHS OF FOLLOW-UP OR EVIDENCE OF HEALING. THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED IN THE (B)(6) HOSPITAL¿S ORTHOPEDIC INPATIENT DATABASE: LFN GROUP: PATIENT 5: A 32-YEAR-OLD MALE PATIENT HAD A WEAKNESS IN LEG, WHICH RESOLVED WITH PHYSICAL THERAPY. PATIENT 6: AN 81-YEAR-OLD MALE PATIENT HAD A PERSISTENT SWELLING ABOUT KNEE 1.5 YEARS POSTOPERATIVELY, COMPRESSION. PATIENT 8: A 58-YEAR-OLD FEMALE PATIENT HAD A PULMONARY EMBOLISM. PATIENT 9: A 35-YEAR-OLD FEMALE PATIENT HAD DIFFICULT REDUCTION INTRAOPERATIVELY AND HAD RESIDUAL SORENESS AT INCISION SITE POSTOPERATIVELY. PATIENT 13: A 16-YEAR-OLD MALE PATIENT HAD PAIN WITH IMPLANTS LEADING TO REHOSPITALIZATION FOR ADJUNCTIVE PLATE REMOVAL, LFN WAS NOT

  Patient problems: Physical Asymmetry

  MAUDE report 15084169 ↗
• InjuryJul 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DDRA) [SUMMARY OF RETROSPECTIVE DATA FOR PATIENTS TREATED WITH THE LATERAL FEMORAL NAIL, ADOLESCENT LATERAL FEMORAL NAIL, AND THE FEMORAL RECON NAIL]. BETWEEN JANUARY 2014 AND OCTOBER 2021, A TOTAL OF 300 PATIENTS (219 PATIENTS TREATED WITH LFN, 56 PATIENTS TREATED WITH ALFN, AND 25 PATIENTS TREATED WITH FRN) WERE INCLUDED IN THE REPORT IF THEY HAD EITHER 9 MONTHS OF FOLLOW-UP OR EVIDENCE OF HEALING. THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED IN THE BRONSON METHODIST HOSPITAL¿S ORTHOPEDIC INPATIENT DATABASE: LFN GROUP: PATIENT 5: A 32-YEAR-OLD MALE PATIENT HAD A WEAKNESS IN LEG, WHICH RESOLVED WITH PHYSICAL THERAPY. PATIENT 6: AN 81-YEAR-OLD MALE PATIENT HAD A PERSISTENT SWELLING ABOUT KNEE 1.5 YEARS POSTOPERATIVELY, COMPRESSION. PATIENT 8: A 58-YEAR-OLD FEMALE PATIENT HAD A PULMONARY EMBOLISM. PATIENT 9: A 35-YEAR-OLD FEMALE PATIENT HAD DIFFICULT REDUCTION INTRAOPERATIVELY AND HAD RESIDUAL SORENESS AT INCISION SITE POSTOPERATIVELY. PATIENT 13: A 16-YEAR-OLD MALE PATIENT HAD PAIN WITH IMPLANTS LEADING TO REHOSPITALIZATION FOR ADJUNCTIVE PLATE REMOVAL, L

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15083622 ↗
• InjuryJul 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DDRA) [SUMMARY OF RETROSPECTIVE DATA FOR PATIENTS TREATED WITH THE LATERAL FEMORAL NAIL, ADOLESCENT LATERAL FEMORAL NAIL, AND THE FEMORAL RECON NAIL]. BETWEEN JANUARY 2014 AND OCTOBER 2021, A TOTAL OF 300 PATIENTS (219 PATIENTS TREATED WITH LFN, 56 PATIENTS TREATED WITH ALFN, AND 25 PATIENTS TREATED WITH FRN) WERE INCLUDED IN THE REPORT IF THEY HAD EITHER 9 MONTHS OF FOLLOW-UP OR EVIDENCE OF HEALING. THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED IN THE (B)(6) HOSPITAL¿S ORTHOPEDIC INPATIENT DATABASE: LFN GROUP: PATIENT 5: A 32-YEAR-OLD MALE PATIENT HAD A WEAKNESS IN LEG, WHICH RESOLVED WITH PHYSICAL THERAPY. PATIENT 6: AN 81-YEAR-OLD MALE PATIENT HAD A PERSISTENT SWELLING ABOUT KNEE 1.5 YEARS POSTOPERATIVELY, COMPRESSION. PATIENT 8: A 58-YEAR-OLD FEMALE PATIENT HAD A PULMONARY EMBOLISM. PATIENT 9: A 35-YEAR-OLD FEMALE PATIENT HAD DIFFICULT REDUCTION INTRAOPERATIVELY AND HAD RESIDUAL SORENESS AT INCISION SITE POSTOPERATIVELY. PATIENT 13: A 16-YEAR-OLD MALE PATIENT HAD PAIN WITH IMPLANTS LEADING TO REHOSPITALIZATION FOR ADJUNCTIVE PLATE REMOVAL, LFN WAS NOT

  Patient problems: Fatigue; Impaired Healing

  MAUDE report 15066499 ↗
• InjuryJul 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DDRA) [SUMMARY OF RETROSPECTIVE DATA FOR PATIENTS TREATED WITH THE LATERAL FEMORAL NAIL, ADOLESCENT LATERAL FEMORAL NAIL, AND THE FEMORAL RECON NAIL]. BETWEEN JANUARY 2014 AND OCTOBER 2021, A TOTAL OF 300 PATIENTS (219 PATIENTS TREATED WITH LFN, 56 PATIENTS TREATED WITH ALFN, AND 25 PATIENTS TREATED WITH FRN) WERE INCLUDED IN THE REPORT IF THEY HAD EITHER 9 MONTHS OF FOLLOW-UP OR EVIDENCE OF HEALING. THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED IN THE BRONSON METHODIST HOSPITAL¿S ORTHOPEDIC INPATIENT DATABASE: LFN GROUP: PATIENT 5: A 32-YEAR-OLD MALE PATIENT HAD A WEAKNESS IN LEG, WHICH RESOLVED WITH PHYSICAL THERAPY. PATIENT 6: AN 81-YEAR-OLD MALE PATIENT HAD A PERSISTENT SWELLING ABOUT KNEE 1.5 YEARS POSTOPERATIVELY, COMPRESSION. PATIENT 8: A 58-YEAR-OLD FEMALE PATIENT HAD A PULMONARY EMBOLISM. PATIENT 9: A 35-YEAR-OLD FEMALE PATIENT HAD DIFFICULT REDUCTION INTRAOPERATIVELY AND HAD RESIDUAL SORENESS AT INCISION SITE POSTOPERATIVELY. PATIENT 13: A 16-YEAR-OLD MALE PATIENT HAD PAIN WITH IMPLANTS LEADING TO REHOSPITALIZATION FOR ADJUNCTIVE PLATE REMOVAL, L

  Patient problems: Post Operative Wound Infection

  MAUDE report 15054960 ↗
• InjurySep 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ORIGINAL DATE OF THE IMPLANT WAS ON (B)(6) 2020.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12428630 ↗
• InjuryJul 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 THAT THE PATIENT UNDERWENT THE REMOVAL OF IMPLANTS DUE TO AN INFECTED NONUNION OF THE RIGHT TIBIA. ALL DEVICES WERE REMOVED SUCCESSFULLY. THERE WERE NO BROKEN IMPLANTS. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE ORIGINAL DATE OF IMPLANT WAS (B)(6) 2020. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 42MM FOR IM NAILS. THIS IS REPORT 5 OF 6 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 12204756 ↗
• InjuryMay 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT A REVISION SURGERY DUE TO A NON-UNION OF THE LEFT TIBIAL SHAFT. THE IMPLANTS THAT WERE REMOVED WERE TITANIUM CANNULATED TIBIAL NAIL, END CAP, AND THREE TITANIUM LOCKING SCREWS. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 42MM FOR IM NAILS. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11894314 ↗
• InjuryJan 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT HAD A PROXIMAL FEMUR FRACTURE THAT WAS TREATED WITH A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) ON (B)(6) 2020, AND THE PATIENT FAILED TO HEAL. THE SURGEON DECIDED TO CONVERT THE PATIENT TO A TOTAL HIP REPLACEMENT SURGERY. REMOVAL OF THE TFNA WAS REQUIRED TO PROCEED WITH THE DESIRED PROCEDURE DUE TO NON-UNION. PROCEDURE OUTCOME IS UNKNOWN. THERE WAS PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 42MM FOR IM NAILS. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11214577 ↗
• InjuryNov 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT UNDERWENT REMOVAL OF ONE (1) TITANIUM RETRO/ ANTEGRADE FEMORAL NAIL AND FOUR (4) TITANIUM LOCKING SCREWS DUE TO PAIN. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 42MM FOR IM NAILS. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 10843700 ↗
• InjuryNov 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT UNDERWENT REMOVAL OF ONE (1) TITANIUM RETRO/ ANTEGRADE FEMORAL NAIL AND FOUR (4) TITANIUM LOCKING SCREWS DUE TO PAIN. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 42MM FOR IM NAILS. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 10843696 ↗
• InjuryNov 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT UNDERWENT REMOVAL OF ONE (1) TITANIUM RETRO/ANTEGRADE FEMORAL NAIL AND FOUR (4) TITANIUM LOCKING SCREWS DUE TO PAIN. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 42MM FOR IM NAILS. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 10843684 ↗
• InjuryNov 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT UNDERWENT REMOVAL OF ONE (1) TITANIUM RETRO/ANTEGRADE FEMORAL NAIL AND FOUR (4) TITANIUM LOCKING SCREWS DUE TO PAIN. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 42MM FOR IM NAILS. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 10843678 ↗
• InjuryMar 31, 2020No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT REMOVAL OF TITANIUM CANNULATED TIBIAL NAIL, TITANIUM LOCKING SCREW 42MM AND TITANIUM LOCKING SCREW 34MM DUE TO HYPERTROPHIC NONUNION 15 MONTHS POSTOPERATIVELY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 42MM FOR IM NAILS. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 9904209 ↗
• InjuryApr 8, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY OF A FEMUR FRACTURE DUE TO NONUNION, UPPER THIGH PAIN, DELAYED HEALING, AND SUBSEQUENT BREAKING OF ONE (1) TITANIUM LOCKING SCREW W/T25 STARDRIVE 2MM FOR INTRAMEDULLARY NAILS (IM). THE SCREW WAS ONE OF TWO DISTAL INTERLOCKING SCREWS, BUT THIS WAS THE ONLY SCREW THAT WAS BROKEN. THE PROXIMAL SEGMENT OF THE TROCHANTERIC FEMORAL NAIL ADVANCE (TFNA) NAIL WAS BROKEN ABOVE THE HELICAL BLADE/SCREW JUNCTION. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES: TFNA HELICAL BLADE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), TITANIUM LOCKING SCREW W/T25 STARDRIVE 2MM FOR IM (PART: 04.005.532, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A 5.0MM TITANIUM (TI) LOCKING SCREW 42MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Impaired Healing; No Code Available; Pain

  MAUDE report 8492581 ↗
• InjuryOct 19, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018 THE PATIENT UNDERWENT RETROGRADE FEMORAL NAIL WHERE THE SCREW HEAD BROKE OFF DURING INSERTION THROUGH THE NAIL. AS ACTION TAKEN FOR THE PROCEDURE THE SURGEON LEFT THE SCREW IN THE PATIENT. THERE WAS NO SURGICAL DELAY AND THE FRAGMENTS WERE EASILY REMOVED. THE PROCEDURE WAS SUCCESSFUL. CONCOMITANT DEVICES REPORTED: FEMORAL NAIL- STERILE ( PART# 04.013.648S, LOT# H075468, QUANTITY# 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7987080 ↗
• InjuryJul 18, 2018Break; Break

  THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 54MM FOR IM NAILS.

  Patient problems: Impaired Healing; No Code Available

  MAUDE report 7698747 ↗
• InjuryJul 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PATIENT COMPLAINED PAIN AND THE PATIENT FELT THROUGH THE SKIN THAT THE MEDIAL DISTAL SIDE OF THE TITANIUM LOCKING SCREW HEAD OF THE TIBIAL NAIL WAS PROMINENT. THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2018. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE DEVICE WAS EXPLANTED. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN TIBIAL NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 42MM FOR IM NAILS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 7682777 ↗
• InjuryApr 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT UNDERWENT INITIAL SURGERY FOR THE INSERTION OF A TIBIAL NAIL. POST-OPERATIVE, PATIENT HAD BONE INFECTION AND NON-UNION. A HARDWARE REMOVAL AND REVISION SURGERY WAS PERFORMED ON (B)(6) 2018. AN 11 MM TI CANNULATED TIBIAL NAIL AND FOUR (4) 5.0 MM TI LOCKING SCREWS WERE REMOVED SUCCESSFULLY AND ALL INTACT. THE REVISION SURGERY ENTAILED THE INSERTION OF AN ANTIBIOTIC NAIL UNTIL THE BONE INFECTION CLEARS AND WILL EVENTUALLY BE REPLACED WITH ANOTHER TIBIAL NAIL. THERE WERE NO SURGICAL DELAYS, SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT OUTCOME WAS REPORTED AS STABLE. THIS REPORT IS FOR ONE (1) 5.0 MM TI LOCKING SCREW W/T25 STARDRIVE 42 MM FOR IM NAILS. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 7402425 ↗
• InjuryApr 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT UNDERWENT INITIAL SURGERY FOR THE INSERTION OF A TIBIAL NAIL. POST-OPERATIVE, PATIENT HAD BONE INFECTION AND NON-UNION. A HARDWARE REMOVAL AND REVISION SURGERY WAS PERFORMED ON (B)(6) 2018. AN 11 MM TI CANNULATED TIBIAL NAIL AND FOUR (4) 5.0 MM TI LOCKING SCREWS WERE REMOVED SUCCESSFULLY AND ALL INTACT. THE REVISION SURGERY ENTAILED THE INSERTION OF AN ANTIBIOTIC NAIL UNTIL THE BONE INFECTION CLEARS AND WILL EVENTUALLY BE REPLACED WITH ANOTHER TIBIAL NAIL. THERE WERE NO SURGICAL DELAYS, SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT OUTCOME WAS REPORTED AS STABLE. THIS REPORT IS FOR ONE (1) 5.0 MM TI LOCKING SCREW W/T25 STARDRIVE 42 MM FOR IM NAILS. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 7402424 ↗
• InjuryApr 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT UNDERWENT INITIAL SURGERY FOR THE INSERTION OF A TIBIAL NAIL. POST-OPERATIVE, PATIENT HAD BONE INFECTION AND NON-UNION. A HARDWARE REMOVAL AND REVISION SURGERY WAS PERFORMED ON (B)(6) 2018. AN 11MM TI CANNULATED TIBIAL NAIL AND FOUR (4) 5.0MM TI LOCKING SCREWS WERE REMOVED SUCCESSFULLY AND ALL INTACT. THE REVISION SURGERY ENTAILED THE INSERTION OF AN ANTIBIOTIC NAIL UNTIL THE BONE INFECTION CLEARS AND WILL EVENTUALLY BE REPLACED WITH ANOTHER TIBIAL NAIL. THERE WERE NO SURGICAL DELAYS, SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT OUTCOME WAS REPORTED AS STABLE. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 42MM FOR IM NAILS. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 7402419 ↗
• InjuryApr 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT UNDERWENT INITIAL SURGERY FOR THE INSERTION OF A TIBIAL NAIL. POST-OPERATIVE, PATIENT HAD BONE INFECTION AND NON-UNION. A HARDWARE REMOVAL AND REVISION SURGERY WAS PERFORMED ON (B)(6) 2018. AN 11 MM TI CANNULATED TIBIAL NAIL AND FOUR (4) 5.0 MM TI LOCKING SCREWS WERE REMOVED SUCCESSFULLY AND ALL INTACT. THE REVISION SURGERY ENTAILED THE INSERTION OF AN ANTIBIOTIC NAIL UNTIL THE BONE INFECTION CLEARS AND WILL EVENTUALLY BE REPLACED WITH ANOTHER TIBIAL NAIL. THERE WERE NO SURGICAL DELAYS, SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT OUTCOME WAS REPORTED AS STABLE. THIS REPORT IS FOR ONE (1) 5.0 MM TI LOCKING SCREW W/T25 STARDRIVE 42 MM FOR IM NAILS. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 7402418 ↗
• InjuryJan 5, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION OF TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) ON (B)(6) 2017 DUE TO NON-UNION, BROKEN TFNA NAIL AND BROKEN TFNA DISTAL LOCKING SCREW. THE PATIENT IS REPORTED TO HAVE BEEN NON-COMPLIANT AND WALKED WITHOUT CANES OR CRUTCHES AS OPPOSED TO THE POST-OPERATIVE INSTRUCTIONS FOR THE FIRST THREE MONTHS AFTER THE INITIAL PROCEDURE THAT WAS CONDUCTED ABOUT SIX MONTHS PRIOR TO THE REVISION SURGERY. THE TFNA NAIL AND DISTAL LOCKING SCREW WERE OBSERVED TO BE BROKEN DURING A FOLLOW-UP X-RAY AFTER INITIAL SURGERY. NAIL WAS BROKEN JUST PROXIMAL TO THE LAG SCREW INSERTION HOLE. THE REMOVED HARDWARE INCLUDED ONE BROKEN TFNA NAIL, ONE INTACT LAG SCREW AND ONE BROKEN 5.0 MM DISTAL LOCKING SCREW. THE PATIENT WAS REVISED TO UNKNOWN QUANTITY OF 95-DEGREE CONDYLAR BLADE PLATES AND 4.5 MM CORTICAL SCREW CONSTRUCT ON THE PROXIMAL FEMUR. ALLOGRAFTS AND AUTOGRAFTS WERE USED TO TREAT THE NONUNION. THE LAG SCREW SITE WAS FILLED WITH NORIAN. DURING THE REVISION SURGERY, THE SURGEON USED A HELICAL BLADE COUPLING SCREW INTO THE DISTAL PORTION OF THE NAIL SO AS TO REMOVE THE DISTAL PART OF THE NAIL FROM THE PATIENT. DURING THE REMOVAL OF THIS PORTION OF THE NAIL, T

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 7169248 ↗