MAUDE Adverse Event Report: ZIMMER, INC. TIBIAL CUT GUIDE RIGHT MEDIAL 5 DEGREES; GAUGE, DEPTH

Catalog Number 42539905285

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/09/2017

Event Type  malfunction  

Manufacturer Narrative

Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.(b)(4).

Event Description

It was reported the drill pin bent and cold welded to the cutting block during surgery.Attempts have been made and additional information on the reported event is unavailable.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

The follow-up report is being submitted to relay additional information.Udi: (b)(4).

Manufacturer Narrative

(b)(4).Medical product: catalog #: 00590102000, headless trocar drill pin, lot # n/a; catalog #: 00590102000, headless trocar drill pin, lot # n/a.The pins were not returned but the tibial cut guide was received for evaluation and the complaint was confirmed.A visual review of the returned device identified galling in the guide holes and one of the holes only accepts below specifications gauge pin.Review of manufacturing records found the guide holes were inspected and accepted.Further review, confirmed the hardness was within specification.This type of event can occur and risks are addressed in risk documentation.However, a definitive root cause cannot be determined 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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-00287 and 00288.

• Brand Name: TIBIAL CUT GUIDE RIGHT MEDIAL 5 DEGREES
• Type of Device: GAUGE, DEPTH
• 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: 6414664
• MDR Text Key: 70310355
• Report Number: 0001822565-2017-01764
• Device Sequence Number: 1
• Product Code: HTJ
• 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,Followup
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 42539905285
• Device Lot Number: 63512100
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1