NA 212.134Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982152060), received between Dec 11, 2017 and Oct 5, 2020 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K000684); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 5, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING OPEN REDUCTION INTERNAL FIXATION (ORIF) LT DISTAL TIBIA FRACTURE THE SURGEON REMARKED 3.5 LOCKING SCREW 42MM AND 3.5 LOCKING SCREW 44MM WOULD NOT LOCK INTO MEDIAL DISTAL TIBIA PLATE. THE SURGEON LEFT ALL THREE IMPLANTS IN THE PATIENT. THERE WAS A SURGICAL DELAY OF TEN MINUTES. THE PATIENT OUTCOME WAS GOOD. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) 3.5MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 44MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10627658 ↗
• InjuryJan 30, 2020Adverse 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 UNDERWENT AN EMERGENT INCISION AND DRAINAGE AND OPEN REDUCTION INTERNAL FIXATION (ORIF) RIGHT TIBIA DUE TO OSTEOMYELITIS AND INFECTION. ON AN UNKNOWN DATE THE PATIENT FELL WITH HER LEG WENT BEHIND HER, FRACTURING HER TIBIA. SHE ALSO HAD AN OPEN DEHISCENCE OF HER SURGICAL WOUND ON THE KNEE. DUE TO THE BEND OF THE KNEE AND THE SPLIT OF THE SKIN, SHE HAS BEEN BLEEDING AND HAS AN OPENING ON HER KNEE REPLACEMENT. ON (B)(6) 2019 THE PATIENT UNDERWENT AN OPEN TREATMENT OF TIBIAL SHAFT FRACTURE ON THE RIGHT SIDE WITH AN INTERNAL FIXATION WITH PLATE; A SECONDARY CLOSURE OF THE SURGICAL WOUND DEHISCENCE, AND AN EXTENSIVE AND COMPLICATED 8CM AND ARTHROTOMY KNEE WITH EXPLORATION AND DRAINAGE OF THE RIGHT KNEE, WHERE THE KNEE REPLACEMENT IS LOCATED. THIS REPORT IS FOR ONE (1) 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 44MM. THIS IS REPORT 5 OF 9 FOR (B)(4). THIS REPORT IS LINKED TO (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9649420 ↗
• MalfunctionApr 8, 2018Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL WHEN PLACING THE FIRST ANCHOR, THE SUTURE SNAPPED ALTHOUGH NOT MUCH FORCE WAS USED ON IT. THE PROCEDURE WAS COMPLETED WITH SAME LIKE PRODUCT. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE AFFILIATE ON (B)(6) 2017 IT IS UNKNOWN WHAT TYPE OF PROCEDURE THIS WAS IT IS UNKNOWN IF THE ANCHOR WAS REMOVED WHEN THE SUTURE BROKE IT IS UNKNOWN IF THE SURGEON USED THE ORIGINAL BONE HOLE TO COMPLETE THE PROCEDURE WHEN WAS THE ISSUE DETECTED- UNK IT IS UNKNOWN IF THERE WAS A RESULTING SURGICAL DELAY THE PROCEDURE WAS ABLE TO BE COMPLETED IT IS UNKNOWN IF ALTERNATIVES WERE READILY AVAILABLE NO PATIENT IMPACT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7405962 ↗
• InjuryDec 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORT THAT THE PATIENT HAD ORIGINAL SURGERY ON (B)(6) 2016 FOR TREATMENT OF A TIBIAL FRACTURE. PATIENT WAS IMPLANTED WITH ONE (1) 3.5MM LOCKING COMPRESSION RECONSTRUCTION PLATE 10 HOLES/140MM, THREE (3) 3.5MM LOCKING SCREWS WITH RECESS 38MM AND ONE (1)3.5MM LOCKING SCREW WITH RECESS 44MM. ON AN UNKNOWN DATE POST-OPERATIVE, PATIENT WAS PRESENTED WITH EXPOSURE OF HARDWARE AT THE TIBIA BONE. THE SOFT TISSUE HAD ERODED AROUND THE CONSTRUCT IMPLANT SITE. ON (B)(6) 2017, SURGEON REMOVED ALL IMPLANTS. THE TIBIAL BONE FRACTURED HAS HEALED, SO NO NEW BONE FIXATION WAS NEEDED. NO INFECTION WAS REPORTED AND IT WAS OBSERVED THAT THE IMPLANTS WERE IN GOOD CONDITION WHEN REMOVED. NO FRAGMENTS WERE GENERATED DURING IMPLANT REMOVAL. REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO TIME DELAY. PATIENT WAS REPORTED IN STABLE CONDITION. THIS REPORT IS FOR ONE (1) 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE¿ RECESS 44MM. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7104952 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000684. 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,