MAUDE Adverse Event Report: ZIMMER BIOMET / ZIMMER, INC. ZIMMER BIOMET TIP STEINMANN PIN; PIN, FIXATION, SMOOTH

Model Number 405800

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/02/2023

Event Type  Injury  

Event Description

Pt underwent a left total shoulder arthroplasty, scrub tech noted that the drill bit used during the case had a broken tip; surgeon notified; xray obtained and broken tip of the drill bit was noted in the glenoid.

• Brand Name: ZIMMER BIOMET TIP STEINMANN PIN
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): ZIMMER BIOMET / ZIMMER, INC.
• MDR Report Key: 16398108
• MDR Text Key: 309882369
• Report Number: MW5115007
• Device Sequence Number: 1
• Product Code: HTY
• 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: 02/14/2023

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 Operator: Health Professional
• Device Expiration Date: 09/12/2023
• Device Model Number: 405800
• Device Lot Number: 246990
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American