MAUDE Adverse Event Report: ZIMMER, INC. MIS QUAD-SPARING TOTAL KNEE SCREW INSERTER / EXTRACTOR; INSTRUMENT, KNEE.

Catalog Number 00598304900

Device Problem Disassembly (1168)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2016

Event Type  malfunction  

Event Description

It was reported the screw inserter disengaged and spins.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The product was returned and an examination of the returned part showed wear & tear that indicates successful use during a potential field age of approximately 10 years.The tip of the device could not rotate when the body was rotated.This confirmed the complaint as the weld joining magnetic tip to the body was fractured.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.The root cause is considered to be a previously addressed design issue.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: MIS QUAD-SPARING TOTAL KNEE SCREW INSERTER / EXTRACTOR
• Type of Device: INSTRUMENT, KNEE.
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6252138
• MDR Text Key: 64890205
• Report Number: 0001822565-2017-00222
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/03/2017

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: 00598304900
• Device Lot Number: 60852314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2016
• Initial Date FDA Received: 01/13/2017
• Supplement Dates Manufacturer Received: 10/31/2017
• Supplement Dates FDA Received: 11/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2007
• 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