NA 412.105Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982210388), received between Aug 14, 2019 and Apr 23, 2021 — classified as 4 injuries.

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

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.

• InjuryApr 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, AN UNKNOWN HARDWARE REMOVAL PROCEDURE WAS PERFORMED FOR UNKNOWN REASON. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES THIRTEEN (13) DEVICES. THIS REPORT IS FOR (1) 3.5 TI LCKNG SCR SLF-TPNG SD RECESS 18. THIS REPORT IS 9 OF 11 (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11717888 ↗
• InjuryAug 14, 2019Break; Break

  UPDATED: CONCOMITANT DEVICES REPORTED: UNKNOWN SCREW: TRAUMA (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). TI LCP WRIST FUSION STANDARD BEND PLATE (PART# 04.110.150, LOT# H582221, QUANTITY# 1). 3.5MM TI STARDRIVE CORTEX SCREW SELF-TAPPING 18MM (PART# 04.200.018 LOT#:L886599, QUANTITY#1). 3.5MM TI LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 18MM (PART# 412.105, LOT# 9396193 , QUANTITY# 1). 3.5MM TI LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 18MM (PART# 412.105, LOT# 9926803 , QUANTITY# 1). 3.5MM TI LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 18MM (PART# 412.105, LOT# L690558 , QUANTITY# 1) .

  Patient problems: No Code Available

  MAUDE report 8895391 ↗
• InjuryAug 14, 2019Break; Break

  UPDATED: CONCOMITANT DEVICES REPORTED: UNKNOWN SCREW: TRAUMA (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1) . TI LCP WRIST FUSION STANDARD BEND PLATE (PART# 04.110.150, LOT# H582221, QUANTITY# 1) . 3.5MM TI STARDRIVE CORTEX SCREW SELF-TAPPING 18MM (PART# 04.200.018 LOT#:L886599, QUANTITY#1). 3.5MM TI LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 18MM (PART# 412.105, LOT# 9396193 , QUANTITY# 1) . 3.5MM TI LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 18MM (PART# 412.105, LOT# 9926803 , QUANTITY# 1) . 3.5MM TI LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 18MM (PART# 412.105, LOT# L690558 , QUANTITY# 1).

  Patient problems: No Code Available

  MAUDE report 8895378 ↗
• InjuryAug 14, 2019Break; Break

  UPDATED: CONCOMITANT DEVICES REPORTED: UNKNOWN SCREW: TRAUMA (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1) . TI LCP WRIST FUSION STANDARD BEND PLATE (PART# 04.110.150, LOT# H582221, QUANTITY# 1) . 3.5MM TI STARDRIVE CORTEX SCREW SELF-TAPPING 18MM (PART# 04.200.018 LOT#:L886599, QUANTITY#1) . 3.5MM TI LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 18MM (PART# 412.105, LOT# 9396193 , QUANTITY# 1) . 3.5MM TI LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 18MM (PART# 412.105, LOT# 9926803 , QUANTITY# 1) . 3.5MM TI LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 18MM (PART# 412.105, LOT# L690558 , QUANTITY# 1).

  Patient problems: No Code Available

  MAUDE report 8895373 ↗

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,