MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. DRIVER U-JOINT ANCHORED LATERAL; SCREWDRIVER

Catalog Number 8630-0004

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2020

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.

Event Description

It was reported that during surgery, the u-joint driver broke during screw installation.The broken piece was retrieved and there was no impact on the patient.

Event Description

It was reported that during surgery, the u-joint driver broke during screw installation.The broken piece was retrieved and there was no impact on the patient.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information and initially corrected information.Summary the complaint is confirmed for one (1) of one (1) returned u-joint driver ( pn 8630-0004) for the failure of fracture.Medical records were not provided for review.Device evaluation: visual inspection of 8630-0004 revealed that it was fractured.Potential cause root cause was unable to be determined.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.Dhr review and related actions per dhr review, the part was likely conforming when it left zimmer biomet control.No actions required.This event is not related to any current actions or recalls or product holds.Device use this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.

• Brand Name: DRIVER U-JOINT ANCHORED LATERAL
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 11117448
• MDR Text Key: 226658701
• Report Number: 3012447612-2020-00691
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 04/22/2021

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 Catalogue Number: 8630-0004
• Device Lot Number: TU01299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 01/05/2021
• Supplement Dates Manufacturer Received: 04/20/2021
• Supplement Dates FDA Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Weight: 98