MAUDE Adverse Event Report: DEPUY (IRELAND) DEPUY 3.2 DRILL BIT; INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMEN

Catalog Number 7505-10-105

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/09/2022

Event Type  malfunction  

Event Description

Describe event, problem, or product use error: depuy size 3.2 drill bit ref# 7505-10-105 lot# 203017, the tip broke off in the left shoulder.

• Brand Name: DEPUY 3.2 DRILL BIT
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMEN
• Manufacturer (Section D): DEPUY (IRELAND)
• MDR Report Key: 15800239
• MDR Text Key: 303929316
• Report Number: MW5113271
• Device Sequence Number: 1
• Product Code: KIJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 7505-10-105
• Device Lot Number: 203017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/14/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White