NA 04.005.422Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982085344), received between Jan 19, 2018 and Jan 26, 2023 — classified as 8 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

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.

• InjuryJan 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023 DURING INTRA-OP PATIENT REQUESTED TO HAVE BIL EX TIBIA NAILS, AND SCREWS, REMOVED DUE TO PAIN AND IRRITATION. THE IMPLANTS ON THE RIGHT SIDE WERE REMOVED WITHOUT INCIDENT. THE IMPLANTS ON THE LEFT WERE DIFFICULT. THE END CAP WAS REMOVED, AND NAIL EXTRACTOR THREADED INTO NAIL. THE DISTAL SCREW WAS REMOVED. WHILE ATTEMPTING TO REMOVE PROXIMAL SCREW, THE SCREW HEAD BROKE OFF OF THE SHAFT, AND LOOKED TO BE COLD WELDED INTO THE HEAD OF THE SCREW. THE BROKEN SCREW REMOVAL SET WAS OPENED AND SURGEON ATTEMPTED TO GET SCREW SHAFT OUT OF NAIL/TIBIA. THE BROKEN SCREW REMOVAL INSTRUMENTS WERE UNABLE TO ASSIST IN REMOVING THE SCREW SHAFT. THE SURGEON HAD TO OPEN SKIN MEDIALLY, AND USE AN OSTEOTOME TO CUT BONE AWAY FROM SCREW ON LATERAL AND MEDIAL SIDES. HE WAS THEN ABLE TO TAMP THE SCREW SHAFT OUT OF PATIENT. HE THEN PROCEEDED TO REMOVE THE NAIL. THERE WAS SURGICAL DELAY OF SIXTY (60) MINUTES. ACTION WAS TAKEN OF OPENED ADDITIONAL SETS/INSTRUMENTS, X-RAY WERE TAKEN AND THERE WERE FRAGMENTS GENERATED AND THE FRAGMENTS WERE REMOVED EASILY WITHOUT ANY ADDITIONAL INTERVENTION. SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT CONSEQUENCES ARE UNKNOWN. THIS COMPLAINT IN

  Patient problems: Pain; Skin Inflammation/ Irritation

  MAUDE report 16247491 ↗
• InjuryJan 26, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023 DURING INTRA-OP PATIENT REQUESTED TO HAVE BIL EX TIBIA NAILS, AND SCREWS, REMOVED DUE TO PAIN AND IRRITATION. THE IMPLANTS ON THE RIGHT SIDE WERE REMOVED WITHOUT INCIDENT. THE IMPLANTS ON THE LEFT WERE DIFFICULT. THE END CAP WAS REMOVED, AND NAIL EXTRACTOR THREADED INTO NAIL. THE DISTAL SCREW WAS REMOVED. WHILE ATTEMPTING TO REMOVE PROXIMAL SCREW, THE SCREW HEAD BROKE OFF OF THE SHAFT, AND LOOKED TO BE COLD WELDED INTO THE HEAD OF THE SCREW. THE BROKEN SCREW REMOVAL SET WAS OPENED AND SURGEON ATTEMPTED TO GET SCREW SHAFT OUT OF NAIL/TIBIA. THE BROKEN SCREW REMOVAL INSTRUMENTS WERE UNABLE TO ASSIST IN REMOVING THE SCREW SHAFT. THE SURGEON HAD TO OPEN SKIN MEDIALLY, AND USE AN OSTEOTOME TO CUT BONE AWAY FROM SCREW ON LATERAL AND MEDIAL SIDES. HE WAS THEN ABLE TO TAMP THE SCREW SHAFT OUT OF PATIENT. HE THEN PROCEEDED TO REMOVE THE NAIL. THERE WAS SURGICAL DELAY OF SIXTY (60) MINUTES. ACTION WAS TAKEN OF OPENED ADDITIONAL SETS/INSTRUMENTS, X-RAY WERE TAKEN AND THERE WERE FRAGMENTS GENERATED AND THE FRAGMENTS WERE REMOVED EASILY WITHOUT ANY ADDITIONAL INTERVENTION. SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT CONSEQUENCES ARE UNKNOWN. THIS COMPLAINT IN

  Patient problems: Pain; Skin Inflammation/ Irritation

  MAUDE report 16247295 ↗
• InjuryJan 6, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE TWO (2) TITANIUM LOCKING SCREW INSERTED DISTALLY CREATED FRACTURE RESULTING IN NAIL DISTAL PENETRATION OF HUMERUS POSTERIOR WALL. DRILL BIT WAS BROKEN DURING PLATING PORTION. THE TWO PIECES WERE BOTH REMOVED. THERE WAS 90 MINUTES SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICES REPORTED: MULTILOC HUMERAL NAIL (PART# 04.019.270S, LOT# L743741, QUANTITY 1); TITANIUM LOCKING SCREW (PART# 04.005.434, LOT# UNKNOWN, QUANTITY 2). THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 32MM FOR IM NAILS. THIS REPORT IS 1 OF 3 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 13176767 ↗
• InjuryJan 6, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE TWO (2) TITANIUM LOCKING SCREW INSERTED DISTALLY CREATED FRACTURE RESULTING IN NAIL DISTAL PENETRATION OF HUMERUS POSTERIOR WALL. DRILL BIT WAS BROKEN DURING PLATING PORTION. THE TWO PIECES WERE BOTH REMOVED. THERE WAS 90 MINUTES SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICES REPORTED: MULTILOC HUMERAL NAIL (PART# 04.019.270S, LOT# L743741, QUANTITY 1); TITANIUM LOCKING SCREW (PART# 04.005.434, LOT# UNKNOWN, QUANTITY 2). THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) 4.0 TI LCKNG SCR T25 SD 32 FOR IM NAILS. THIS REPORT IS 3 OF 3 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 13176759 ↗
• InjuryOct 4, 2021Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT REMOVAL OF HARDWARE AND REVISION OF TIBIA INTRAMEDULLARY (IM) NAIL DUE TO NON-UNION. A SCREW WAS ALSO BROKEN PRIOR TO SURGERY ON (B)(6) 2021. IT IS UNKNOWN WHEN THE SCREW BROKE. ORIGINAL DATE OF SURGERY WAS ON APRIL 22, 2020. THE NAIL AND SCREWS WERE EXPLANTED SUCCESSFULLY. THE REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY COMPLICATION OR SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 32MM FOR IM NAILS. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; Nonunion/Delayed-union Bone Fracture

  MAUDE report 12571635 ↗
• 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. (B)(4).

  Patient problems: No Code Available

  MAUDE report 9072660 ↗
• 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 8410234 ↗
• InjuryJan 19, 2018Break; Break

  THIS REPORT IS AGAINST USER FACILITY MEDWATCH NUMBER (B)(4), A COPY IS ATTACHED. THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7205460 ↗

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