NA 04.005.424Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982085368), received between Mar 11, 2019 and May 25, 2021 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 25, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE WHEN PUTTING UNKNOWN DISTAL SCREWS INTO THE LONG MULTILOC HUMERAL NAIL THE 4.0MM TITANIUM LOCKING SCREWS THAT WAS USED WAS NOT ENGAGING THE UNKNOWN DISTAL CORTEX. WHEN THE SCREW WAS EXCHANGED FOR A LONGER SCREW THE STAFF BELIEVED THE SCREW THREADS WERE STRIPPED OUT AND COULD NOT ENGAGE THE FAR CORTEX. NO FRAGMENTS GENERATED. NO SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT HARM. CONCOMITANT DEVICE REPORTED: UNK: NAILS: HUMERAL (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). UNK: SCREWS: NAIL DISTAL LOCKING (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). UNK: SCREWDRIVERS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS COMPLAINT INVOLVES (2) DEVICES. THIS REPORT IS FOR (1) 4.0 TI LCKNG SCR T25 SD 34 FOR IM NAILS. THIS REPOT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11881082 ↗
• 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 34 FOR IM NAILS. THIS REPORT IS 4 OF 7 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11802933 ↗
• 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 34 FOR IM NAILS. THIS REPORT IS 1 OF 7 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11802917 ↗
• 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 34 FOR IM NAILS. THIS REPORT IS 7 OF 7 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11802894 ↗
• InjuryJan 15, 2021Adverse 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 REPORT IS FOR (1) 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM FOR IM NAILS. THIS REPORT IS 5 OF 5 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11181764 ↗
• 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 34MM FOR IM NAILS. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11171659 ↗
• InjurySep 16, 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 (38) DEVICES. THIS IS REPORT 9 FOR 10 (B)(4). OTHER DEVICES WAS INCLUDED WITH RELATED INCIDENTS: (B)(4).

  Patient problems: No Code Available

  MAUDE report 9072647 ↗
• InjuryMay 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT HAD HARDWARE REMOVAL OF ONE (1) MULTILOC HUMERAL NAIL, ONE (1) MULTILOC SCREW LENGTH 50MM, ONE (1) MULTILOC SCREW LENGTH 42MM, ONE (1) MULTILOC SCREW LENGTH 48MM, ONE (1) MULTILOC SCREW LENGTH 40MM, ONE (1) TITANIUM LOCKING SCREW LENGTH 34MM, AND ONE (1) TITANIUM LOCKING SCREW LENGTH 36MM DUE TO SHOULDER PAIN AND LIMITED MOBILITY OF HUMERUS. THERE WERE FOUR PART PROXIMAL HUMERUS FRACTURE FIXED WITH THE NAIL BUT THE BONE HAD GONE ON TO DIE. THE SURGEON REMOVED ALL THE IMPLANTS BECAUSE THE HEAD JUST FELL INTO VARIOUS COLLAPSE AND TAKE THE DEAD BONY FRAGMENTS. INITIAL SURGERY WAS DONE ON (B)(6) 2018. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS REPORT IS FOR ONE (1) 4.0MM TI LOCKING SCREW 34MM. THIS IS REPORT 6 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Necrosis; No Code Available; Pain

  MAUDE report 8621301 ↗
• 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 8410228 ↗

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