NA 04.005.428Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982085405), received between Oct 23, 2018 and Jul 22, 2022 — classified as 7 injuries, 1 malfunction.

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 8 most recent of 8 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 (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 REVI

  Patient problems: Pain

  MAUDE report 15085191 ↗
• 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: Pain

  MAUDE report 15085017 ↗
• 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 38 FOR IM NAILS. THIS REPORT IS 2 OF 7 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11802867 ↗
• MalfunctionJun 8, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE. DURING THE PROCEDURE, A LOCKING SCREW WAS BENT ON BACK SLAP TECHNIQUE TO CLOSE THE FRACTURE GAP. SCREWS THAT WERE MADE OF COBALT CHROME WERE OFFERED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THE PATIENT OUTCOME WAS AS PLANNED. CONCOMITANT DEVICE REPORTED: NAILS: EXPERT TIBIAL (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM FOR IM NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10127984 ↗
• 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) DEVICES. (B)(4).

  Patient problems: No Code Available

  MAUDE report 9076131 ↗
• InjuryJun 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, PATIENT UNDERWENT REMOVAL OF TITANIUM CANNULATED HUMERAL NAIL EX, TITANIUM LOCKING SCREW 30MM AND TITANIUM LOCKING SCREW 38MM. IMPLANTS WERE REMOVED DUE TO HUMERAL SHAFT NON-UNION. THE PATIENT ORIGINALLY HAD THE HUMERAL NAIL CONSTRUCT IMPLANTED TO TREAT HIS HUMERUS FRACTURE ON AN UNKNOWN DATE. PATIENT WAS REVISED TO A 9 HOLE 4.5MM LCP BROAD PLATE AND EIGHT (8) 4.5MM CORTEX SCREWS. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT DELAY. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 8671564 ↗
• InjuryMar 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  04/16/2019: UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF INTRAMEDULLARY NAIL (IM NAIL) WITH EXCHANGE NAILING OF THE RIGHT TIBIA DUE TO NON-UNION. ALL HARDWARE WAS REMOVED COMPLETELY. NONE OF THE HARDWARE WAS BROKEN. THE MEDULLARY CANAL WAS PREPPED FOR A LARGER TIBIAL NAIL. A 10X360 MM TIBIAL NAIL WAS IMPLANTED AND LOCKED DISMALLY AND PROXIMAL. ORIGINAL IMPLANT DATE WAS ON (B)(6) 2015. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PATIENT WAS STABLE UPON COMPLETION OF THE PROCEDURE. THIS COMPLAINT INVOLVES NINE (9) DEVICES.

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

  MAUDE report 8410196 ↗
• InjuryOct 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT WAS IMPLANTED WITH ONE (1) TITANIUM END CAP T25 STARDRIVE, ONE (1) TITANIUM DISTAL LOCKING SCREW, ONE (1) TITANIUM CANNULATED HUMERAL NAIL-EX, STERILE, ONE (1) 38MM TITANIUM LOCKING SCREW AND ONE (1) TITANIUM SPIRAL BLADE ON AN OPEN REDUCTION INTERNAL FIXATION (ORIF) DUE TO PROXIMAL HUMERAL FRACTURE. AFTER THE INSERTION OF THE TITANIUM CANNULATED HUMERAL NAIL-EX THE BONE FAILED AROUND THE IMPLANT. THE SURGEON REMOVED THE TITANIUM END CAP T25 STARDRIVE, TITANIUM LOCKING SCREW AND THE TITANIUM SPIRAL BLADE AND RE-REDUCED THE HUMERAL HEAD ON TOP OF THE NAIL. THE ONLY IMPLANTS THAT REMAINED IN THE PATIENT WERE THE TITANIUM CANNULATED HUMERAL NAIL-EX AND THE TITANIUM DISTAL LOCKING SCREW. THE SURGEON INDICATED THAT THERE WAS CONCERN WITH THE PATIENTS BONE QUALITY AND POSSIBLY BONE CANCER. THERE WAS A NOTED ABNORMALITY ON THE X-RAY AND A CULTURE WAS TAKEN FROM THE POSSIBLE MALIGNANT TUMOR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH SURGICAL DELAY. THIS REPORT IS FOR (1) 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM FOR IM NAILS THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS 4 OF 5 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7997428 ↗

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-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
• 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