MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SCREW INSERTER/EXTRACTOR

Model Number N/A

Device Problem Separation Problem (4043)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned yet.

Event Description

It was reported that during a total knee arthroplasty procedure, the tip of screw inserter disengaged from the screw shaft.A delay less than 30 minutes occurred.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned instrument identified nicks or gouges and the weld had fractured between the magnetic tip end and the main body of the instrument.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was determined to be design deficiency.Investigation into this issue revealed that the weld specification was insufficient for this instrument, and new welding specifications were implemented.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.

• Brand Name: SCREW INSERTER/EXTRACTOR
• Type of Device: EXTRACTOR
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7806497
• MDR Text Key: 118023072
• Report Number: 0001822565-2018-04584
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• 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: 00598304900
• Device Lot Number: 60905999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1