NA 212.118Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982151926), received between Dec 22, 2018 and Oct 5, 2020 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

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. 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.

• 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 W/STARDRIVE RECESS 42MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10627655 ↗
• 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 SELF-TYPING W/STARDRIVE(TM) RECESS 42MM. THIS IS REPORT 4 OF 9 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9649349 ↗
• InjuryDec 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION (ORIF) OF ANKLE DUE TO AN INJURY. THE OPEN DISTAL TIBIA FRACTURE WAS PLATED WITH ONE (1) MEDIAL DISTAL TIBIA PLATE AND ONE (1) LOCKING COMPRESSION PLATE (LCP) PLATE. THE FIBULA WAS ALSO PLATED WITH ONE (1) ONE-THIRD (1/3) TUBULAR PLATE. THE PATIENT HAD AN INFECTION DUE TO THE OPEN FRACTURE AND WAS MADE AWARE ON (B)(6) 2018. A HARDWARE REMOVAL WAS CONDUCTED ON NOVEMBER 30, 2018 FOR ALL PLATES INCLUDING ONE (1) 3.5MM LOCKING SCREW SELF-TAPING WITH STARDRIVE(TM) RECESS 50MM, ONE (1) 3.5MM LOCKING SCREW SELF-TAPING WITH STARDRIVE RECESS 48MM, ONE (1) LOCKING SCREW SELF-TAPING WITH STARDRIVE RECESS 42MM, ONE (1) 3.5MM LOCKING SCREW SELF-TAPING WITH STARDRIVE(TM) RECESS 40MM, ONE (1) 3.5MM LOCKING SCREW SELF-TAPING WITH STARDRIVE(TM) RECESS 18MM, TWO (2) 2.7MM CORTEX SCREW SELF-TAPPING 32MM, ONE (1) 2.7MM CORTEX SCREW SELF-TAPPING 36MM, TWO (2) 3.5MM CORTEX SCREW SELF-TAPPING 38MM, ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 36MM, ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 34MM, FIVE (5) 3.5MM CORTEX SCREW SELF-TAPPING 32MM, AND ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 30MM. IRRIGATION AND DEBRIDEMENT WAS

  Patient problems: Unspecified Infection

  MAUDE report 8193008 ↗

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,