MAUDE Adverse Event Report: ZIMMER, INC. GENDER SOLUTIONS PATELLO-FEMORAL JOINT SYSTEM PFJ MILLING BURR; KNEE INSTRUMENT

Model Number N/A

Device Problems Difficult to Insert (1316); Sticking (1597)

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

Event Type  malfunction  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that the burr was stuck in the power drill and wouldn't function or seat all the way down.

Manufacturer Narrative

This report is being amended to relay updated and corrected information.No product was returned; visual and dimensional evaluations could not be performed.Review of the device history record for [00592705000, 633399269] identified no deviations or anomalies apart from 1 unit being scrapped during the manufacturing process.This device is used for treatment.A complaint history search found no other reports of this nature for this item and lot combination.Per the packaging insert associated with the device at (87-6203-999-23 rev.A) "where instruments form part of a larger assembly, check that the devices assemble readily with mating components." a definitive root cause cannot be determined at this time, with the information provided.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: GENDER SOLUTIONS PATELLO-FEMORAL JOINT SYSTEM PFJ MILLING BURR
• 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: carrie schneider ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5846069
• MDR Text Key: 51120785
• Report Number: 0001822565-2016-02693
• Device Sequence Number: 1
• Product Code: HWE
• 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: 05/05/2017

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 Expiration Date: 04/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 00592705000
• Device Lot Number: 63339269
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2016
• Initial Date FDA Received: 08/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2016
• 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