MAUDE Adverse Event Report: ZIMMER, INC. UNIVERSAL DISPOSABLE DRILL AND PIN SET; KNEE INSTRUMENT

Catalog Number 200100000

Device Problem Sticking (1597)

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

Event Date 07/11/2016

Event Type  malfunction  

Manufacturer Narrative

Information was received from a distributor who is not required to complete form 3500a.This report will be amended when our investigation is complete.

Event Description

It is reported that the drill bit seized in the femoral saw guide.

Manufacturer Narrative

(b)(6).Concomitant products: distal femoral saw guide, catalog #00541300003, lot 61159628.Reported event was unable to be confirmed, as device was not returned.Device history records were reviewed and no discrepancies were found.Review of complaint history determined that no further action is required as no trends were identified.Root cause was determined to be normal wear and tear from use.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.Multiple mdr reports were filed for this event; please see associated reports: 1822565-2016-02756 and 1822565-2016-02752.

• Brand Name: UNIVERSAL DISPOSABLE DRILL AND PIN SET
• Type of Device: KNEE INSTRUMENT
• 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 east bell drive; warsaw, IN 46582-0708 ; 5745273773
• MDR Report Key: 5868781
• MDR Text Key: 52448392
• Report Number: 0001822565-2016-02752
• Device Sequence Number: 1
• Product Code: JWH
• 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: 05/26/2017

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: 200100000
• Device Lot Number: 63338701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2016
• Initial Date FDA Received: 08/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1