MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. DEPUY FEMORAL HEAD IMPACTOR TIP

Device Problems Break (1069); Component Missing (2306)

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

Event Date 10/03/2022

Event Type  malfunction  

Event Description

Small edge of plastic femoral impactor tip broke intraoperatively during total hip arthroscopy.Approximately one-quarter of the proximal lip nearest the threads is missing.No patient harm.Fda safety report id# (b)(4).

• Brand Name: DEPUY FEMORAL HEAD IMPACTOR TIP
• Type of Device: IMPACTOR
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.
• MDR Report Key: 15588809
• MDR Text Key: 301664787
• Report Number: MW5112550
• Device Sequence Number: 1
• Product Code: HWA
• 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: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 122 KG