NA 04.118.520Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982108845), received between Jul 27, 2018 and Jan 29, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K120070, K120717, K120854); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2024Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN ORIF SURGERY FOR A CLAVICLE FRACTURE. THE SURGEON INSERTED THE LOCKING SCREW IN QUESTION INTO THE 3RD HOLE FROM THE DISTAL END. SINCE THE SURGEON FELT THAT HE WAS TIGHTENING THE LOCKING SCREW NORMALLY, HE STOPPED TIGHTENING THE LOCKING SCREW, ALTHOUGH HE FELT THAT THERE WAS A SLIGHT GAP BETWEEN THE SCREW HEAD AND THE PLATE. LOCKING SCREWS WERE THEN INSERTED INTO THE 4TH AND MOST DISTAL HOLE. HOWEVER, AT THIS POINT, THE SURGEON WAS CONCERNED ABOUT THE GAP BETWEEN THE HEAD OF THE SCREW INSERTED IN THE 3RD HOLE FROM THE DISTAL END AND THE PLATE, SO HE RETIGHTENED THAT LOCKING SCREW. WHEN THE SURGEON TRIED TO REMOVE THE SCREWDRIVER FROM THE SCREW HEAD, THE SCREW BROKE OFF AT ITS NECK AND ONLY THE SCREW HEAD WAS ATTACHED TO THE SCREWDRIVER TIP. THE SURGEON INSERTED THE REST OF THE LOCKING SCREWS AND COMPLETED THE SURGERY WITH THE SHAFT OF THE BROKEN LOCKING SCREW REMAINED IN THE PATIENT¿S BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. PATIENT OUTCOME, STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) LWPROF METAPHYS C

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18594713 ↗
• MalfunctionJul 3, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM DEPUY SYNTHESE REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR CLAVICLE MIDSHAFT FRACTURE. AFTER REDUCTION OF THE FRACTURE SITE, A VA CLAVICLE PLATE SHORT 2.7 WAS TEMPORARILY FIXED BY A K-WIRE AND FORCEPS, AND THEN A SCREW WAS INSERTED CENTRALLY. AFTER THAT, THE SCREW IN QUESTION WAS INSERTED HALFWAY IN THE LATERAL HOLE, AND ANOTHER SCREW WAS INSERTED IN THE ADJACENT HOLE TO BRING THE PLATE TO THE BONE. AFTER SCREW INSERTION IN ALL OTHER LATERAL HOLES, AN ATTEMPT WAS MADE TO INSERT THE SCREW THAT HAD BEEN STOPPED BEING INSERTED HALFWAY, AND THE SCREW BROKE OFF AT ITS NECK BEFORE IT WAS FULLY INSERTED. THE PLATE HAD TO BE REMOVED TO EXTRACT THE SCREW SHAFT, BUT BECAUSE THE FIXATION WAS ALMOST FINISHED, THE SCREW SHAFT WAS LEFT IN THE BONE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 2.7MM TI METAPHYSEAL SCR/SLF- TPNG W/T8 STRDRV RECESS/20MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17247482 ↗
• InjuryJul 27, 2018Break; Break

  IT WAS REPORTED THAT DURING ANKLE RECONSTRUCTION ON AN UNKNOWN DATE, THE HEAD OF A 2.7MM TITANIUM (TI) METAPHYSEAL SCREW BROKE OFF WHEN IT WAS POWERED DOWN TO AN UNKNOWN TITANIUM LOCKING COMPRESSION PLATE (LCP) DISTAL TIBIA PLATE WITH AN UNKNOWN DRILL. THE PLATE WAS REMOVED TEMPORARILY TO RETRIEVE THE BROKEN SCREW, THEN THE PLATE WAS PLACED BACK TO FIX THE FRACTURE. THERE WAS AN UNKNOWN SURGICAL DELAY REPORTED. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE: TITANIUM LCP DISTAL TIBIA PLATE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), DRILL (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A 2.7MM TI METAPHYSEAL SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS/20MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7728357 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120070, K120717, K120854. One submission often covers many models, so check the product and lot details in each record.

• Z-0124-2016 · Sep 28, 2015 · Terminated
  Synthes 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm- Sterile and Synthes 2.7MM/3.5MM VA-LCP Extended Medial Distal Humerus Plates 10H/RT/189mm-Sterile The Synthes