NA 207.634Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982148216), received between Apr 23, 2020 and Aug 31, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

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 18, 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.

• MalfunctionAug 31, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SCREW IN QUESTION ARRIVED WITH A VERY HIGH AMOUNT OF SMALL BLACK PARTICLES WITHIN THE SCREW PACKAGING. THERE WAS NO PATIENT CONSEQUENCE AND NO MEDICAL INTERVENTION REQUIRED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 4.0MM CANNULATED SCREW SHORT THREAD/34MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15327248 ↗
• InjuryMay 7, 2021Break; Entrapment of Device; Break; Entrapment of Device

  CONCOMITANT DEVICE REPORTED: UNK - CABLE/WIRE: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). UNK-DRILL (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY:1). THIS REPORT IS FOR ONE (1) 4.0MM CANNULATED SCREW SHORT THREAD/34MM. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS AGAINST USER FACILITY MEDWATCH NUMBER (B)(4), THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 11792711 ↗
• InjuryApr 23, 2020Break; Crack; Break; Crack

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: MURAWSKI, C.D., THREAD DELAMINATION IN 4.5 MM AO CANNULATED SCREWS: A SMALL CASE SERIES IN THE PEDIATRIC TRAUMA POPULATION, VOL. XX (XX), PAGES 1-14 (USA). THE AIM OF THIS RETROSPECTIVE STUDY IS TO REPORT THE OCCURRENCE OF REPEATED HARDWARE FAILURES VIA THREAD DELAMINATION IN THE SETTING OF A COMMONLY USED ORTHOPAEDIC CANNULATED SCREW IMPLANT IN A SMALL COHORT INVOLVING PEDIATRIC FRACTURE CARE AT A SINGLE ACADEMIC LEVEL I TRAUMA CENTER. BETWEEN AUGUST 2015 TO JANUARY 2020, A TOTAL OF 8 PATIENTS WHO HAD HARDWARE FAILURE ASSOCIATED WITH 4.5 MM AO CANNULATED STAINLESS-STEEL SCREWS (DEPUY SYNTHES COMPANIES, JOHNSON & JOHNSON MEDICAL DEVICES; WARSAW, IN) WERE IDENTIFIED. 3 PATIENTS WERE EXCLUDED LEAVING A TOTAL OF 5 PATIENTS (1 MALE AND 4 FEMALE) WITH A MEAN AGE OF 13.8 YEARS (RANGE, 12-15 YEARS) WERE INCLUDED IN THE STUDY. SURGERY WAS PERFORMED USING A 4.5 MM AO CANNULATED SCREWS, OF WHICH 4 PARTIALLY THREADED SCREWS AND ONE WAS A FULLY THREADED CONSTRUCT. THE FOLLOW-UP DURATION WAS UNKNOWN. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 3 PATIENTS WHO WERE EXCLUDED IN THE STUDY HAD A HARDWARE FAILURE.

  Patient problems: No Code Available

  MAUDE report 9993082 ↗