NA 212.108Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982151827), received between Nov 30, 2017 and Aug 21, 2018 — classified as 2 injuries.

1 other recall cover devices cleared under the same FDA submission (K000684, K072095); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON OR AROUND (B)(6) 2016 SURGEON PERFORMED A CORRECTION OF NONUNION OF LEFT SUPRACONDYLAR HUMERUS FRACTURE. DEPUY SYNTHES HARDWARE WAS EXPLANTED AND BONE GRAFT WAS IMPLANTED. SURGEON ALSO PERFORMED NEUROLYSIS OF THE LEFT ULNAR NERVE. DUE TO DATABASE LIMITATIONS, SIX (6) ADDITIONAL DEVICES ARE CAPTURED IN (B)(4) AND SEVEN (7) ADDITIONAL DEVICE ARE CAPTURED UNDER (B)(4). THIS REPORT ADDRESSES DEVICES IDENTIFIED IN ADDITIONAL INFORMATION RECEIVED ON AUGUST 1, 2018. THIS REPORT IS FOR ONE (1) 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 24MM. THIS IS REPORT 4 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7802903 ↗
• InjuryNov 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ORIGINAL SURGERY TO TREAT A LEFT PROXIMAL HUMERUS FRACTURE WAS PERFORMED ON (B)(4) 2017. THE PATIENT WAS IMPLANTED WITH SIXTEEN (16) SYNTHES DEVICES WHICH INCLUDE TWELVE (12) LOCKING SCREWS, THREE (3) CORTEX SCREWS AND ONE (1) PLATE. THE PATIENT RETURNED ON AN UNKNOWN DATE FOR POST-OPERATIVE X-RAYS. THE X-RAYS REVEALED NON-UNION AS THE FRACTURE DID NOT HEAL AS EXPECTED. IT WAS ALSO REPORTED THAT THE PATIENT HAD FALLEN MULTIPLE TIMES POST-OPERATIVELY AND WAS NON-COMPLAINT WITH POST-OPERATIVE CARE. TO ADDRESS THE NON-UNION, SURGEON WILL BE PERFORMING A REVISION FOR HARDWARE REMOVAL ON (B)(6), 2017. IT HAS BEEN DECIDED THAT ALL OF THE 16 IMPLANTED DEVICES WILL BE REMOVED. PATIENT WILL BE REVISED TO A DIFFERENT TREATMENT PLAN AND NO NEW DEVICES WILL BE IMPLANTED; IT IS UNKNOW IF THAT PROCEDURE OCCURRED AS PLANNED. THERE WAS NO REPORTED PRODUCT PROBLEM AND PER THE X-RAYS, THE DEVICES APPEARED TO BE INTACT. THIS IS REPORT 3 OF 16 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7070667 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000684, K072095. One submission often covers many models, so check the product and lot details in each record.

• Z-1800-2015 · May 13, 2015 · Terminated
  3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle,