MAUDE Adverse Event Report: DEPUY SYNTHES/ DEPUY ORTHOPAEDICS DEPUY SYNTHES 2.0MM DRILL BIT; BIT, SURGICAL

Model Number 2.0MM

Patient Problem Insufficient Information (4580)

Event Date 08/15/2023

Event Type  malfunction  

Event Description

Surgeon was performing a right total shoulder arthroplasty on patient and the 2.0 drill bit broke off in the humeral head area of the shoulder.

• Brand Name: DEPUY SYNTHES 2.0MM DRILL BIT
• Type of Device: BIT, SURGICAL
• Manufacturer (Section D): DEPUY SYNTHES/ DEPUY ORTHOPAEDICS; west chester PA 19380
• MDR Report Key: 17651744
• MDR Text Key: 322507145
• Report Number: MW5145057
• Device Sequence Number: 1
• Product Code: GFG
• 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: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2.0MM
• Device Lot Number: 5938P17
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 97 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White