MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FINN SEGMENT HEX DRIVER; INSTRUMENT, KNEE

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 07/06/2023

Event Type  malfunction  

Event Description

It was reported the 3.5 hex driver broke as the surgeon was loosening the femoral screw.No pieces fell into the patient and there was no patient impact.No addtional information is available.

Manufacturer Narrative

(b)(4).The product has been received by zimmerbiomet.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified sign of use and tip was fractured/broken.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were not provided.The root cause of the reported issue is attributed to wear and tear resulting from use.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: FINN SEGMENT HEX DRIVER
• Type of Device: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17436227
• MDR Text Key: 320159751
• Report Number: 0001825034-2023-01785
• Device Sequence Number: 1
• Product Code: HWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/24/2023

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 Model Number: N/A
• Device Catalogue Number: 32-471247
• Device Lot Number: 315470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/10/2023
• Initial Date FDA Received: 08/01/2023
• Supplement Dates Manufacturer Received: 08/23/2023
• Supplement Dates FDA Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose