NA 04.005.432Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982085443), received between Apr 3, 2018 and Jul 22, 2022 — classified as 7 injuries.

The most frequently reported specific device problem is “Device Slipped” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K000089, K103002); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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: Pain

  MAUDE report 15085257 ↗
• InjuryJul 22, 2022Device Slipped; Device Slipped

  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: Insufficient Information

  MAUDE report 15084914 ↗
• InjuryMay 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A HUMERAL NAIL WAS REMOVED DUE TO VARUS COLLAPSE CAUSING NAIL PROMINENCE PROXIMALLY LEADING TO PATIENT DISCOMFORT. FRACTURE HAD HEALED. IMPLANT AND EXPLANT DATES ARE UNKNOWN. THIS IS REPORT 3 OF 3 FOR (B)(4). THIS REPORT IS FOR A LOCKING SCREW.

  Patient problems: Bone Fracture(s); Discomfort

  MAUDE report 14338909 ↗
• InjuryMay 10, 2021Adverse 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 UNDERWENT REMOVAL OF TITANIUM CANNULATED TIBIAL NAIL WITH PROXIMAL BEND AND SIX (6) TITANIUM LOCKING SCREWS DUE TO NONUNION. ALL HARDWARE WAS SUCCESSFULLY REMOVED INTACT. THE REAMER IRRIGATOR ASPIRATOR (RIA) 2 REAMER HEAD BROKE OFF DURING REAMING. PATIENT OUTCOME WAS UNKNOWN. THIS (B)(4) CAPTURES THE POSTOP EVENT REMOVAL, DUE TO NONUNION. (B)(4) CAPTURES THE INTRA-OP EVENT DURING REMOVAL WHEN THE REAMER HEAD BROKE OFF. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR ONE (1) 4.0 TI LCKNG SCR T25 SD 42 FOR IM NAILS. THIS REPORT IS 5 OF 7 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11802938 ↗
• InjuryJan 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, A HARDWARE REMOVAL WAS PERFORMED DUE TO NON-UNION. AN EXPERT TITANIUM CANNULATED TIBIAL NAIL AND FOUR (4) ASSOCIATED 4.0MM TITANIUM LOCKING SCREWS WERE REMOVED FROM THE PATIENT¿S TIBIA. THE MEDULLARY CANAL WAS REAMED, AND A LARGER NAIL WAS IMPLANTED. COMPRESSION OF THE FRACTURE GAP WAS ACHIEVED. HARDWARE WAS REMOVED AND REPLACED WITH LARGER SIZED HARDWARE AND REDUCTION WAS ACHIEVED. IT WAS UNKNOWN IF THE PROCEDURE COMPLETED SUCCESSFULLY. THE PATIENT EXPERIENCED A NONUNION OF THE FRACTURE SITE. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 42MM FOR IM NAILS. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11174056 ↗
• InjurySep 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2019, DURING AN UNKNOWN PROCEDURE, IT WAS FOUND OUT THAT AN UNKNOWN HUMERAL NAIL SET DO NOT HAVE AN UNKNOWN CADDY WITH AN UNKNOWN BLADES, UNKNOWN 4.0 TITANIUM SCREWS AND UNKNOWN END CAPS. ORIGINALLY, THE SALES CONSULTANT GETS THE SET AND THERE¿S GOING TO BE A TOTE WITH IMPLANTS FOR BLADES AND SCREWS AND END CAPS. THE SALES CONSULTANT CALLED THE FSL AND EVENTUALLY DISCOVERED THAT THERE WAS SUPPOSED TO BE A CADDY INSIDE THE SET. THE SALES CONSULTANT THEN GO AND DRIVE TO ANOTHER HOSPITAL AND RETURN WITH A TOTE FOR SAID IMPLANTS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED; HOWEVER, THE PATIENT SPENT AN EXTRA 100 MINUTES UNDER ANESTHESIA. ALSO, THE END CAP AVAILABLE FROM THE OTHER HOSPITAL WAS NOT THE CORRECT SIZE, SO IT PROTRUDED FROM THE PATIENT¿S HUMERAL HEAD. RE-OPERATION IS MOST LIKELY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS COMPLAINT INVOLVES THIRTY-EIGHT (37) DEVICE. THIS IS REPORT 3 FOR 10 (B)(4). OTHER DEVICES WAS INCLUDED WITH RELATED INCIDENTS: (B)(4).

  Patient problems: No Code Available

  MAUDE report 9076141 ↗
• InjuryApr 3, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE SCREWS WOULD NOT GO IN THE AIMING ARM WHEN THE SURGEON WAS ATTEMPTING TO INSERT THE PROXIMAL LOCKING SCREWS IN AN ADOLESCENT FEMORAL NAIL DURING AN INTRAMEDULLARY NAIL OF A FEMUR ON (B)(6) 2018. THE SALES CONSULTANT FURTHER EXPLAINED THAT THE AIMING ARM WOULD ACCEPT THE DRILL BIT, BUT NOT THE SCREWS. THE INSERTION HANDLE AND/OR THE AIMING ARM KEPT THE PROTECTION SLEEVE FROM LINING UP PROPERLY, WHICH EVENTUALLY LED TO THE TRANSVERSE INTERLOCK NOT WORKING PROPERLY AND THEY HAD TO SWITCH THE HOLE AND USE THE ANTEGRADE INTERLOCK TO LOCK THE SCREW AND COMPLETE THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THE PATIENT WAS FINE AT THE END OF THE PROCEDURE. CONCOMITANT DEVICE (S) REPORTED:12.0MM/8.0MM PROTECTION SLEEVE (PART # 03.010.063, UNKNOWN LOT #, QTY # 1). THIS REPORT IS FOR ONE (1) LOCKING SCREW. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7393710 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000089, K103002. One submission often covers many models, so check the product and lot details in each record.

• Z-2059-2012 · May 22, 2012 · Terminated
  4.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012 REF 04.019.038S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Mu
• Z-2060-2012 · May 22, 2012 · Terminated
  4.5mm TI Multiloc Screw Length 28MM-Sterile Expiration: 04/29/2012 REF 04.019.028S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Mu