MAUDE Adverse Event Report: DEPUY SYNTHES / DEPUY ORTHOPAEDICS FORCEPS; REDUCTION FORCEPS

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/10/2022

Event Type  malfunction  

Event Description

During the operative procedure the surgeon was using reduction forceps to reduce the fracture.The tip of the forceps broke while attempting to gain reduction.This happened two times with 2 forceps.The broken tips of both forceps were immediately recovered.An xray was taken to confirm all pieces were recovered.Fda safety report id# (b)(4).

• Brand Name: FORCEPS
• Type of Device: REDUCTION FORCEPS
• Manufacturer (Section D): DEPUY SYNTHES / DEPUY ORTHOPAEDICS
• MDR Report Key: 14855381
• MDR Text Key: 295051448
• Report Number: MW5110582
• Device Sequence Number: 2
• Product Code: HYA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/24/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Sex: Male