MAUDE Adverse Event Report: ZIMMER INC. NEXGEN 0 DEGREE RIGHT CUT GUIDE; GUIDE, SURGICAL

Model Number N/A

Device Problems Mechanical Problem (1384); Difficult to Advance (2920); Material Deformation (2976)

Patient Problem No Information (3190)

Event Date 10/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The reported event is confirmed.As returned cut guide exhibits signs of repeated use (nicked and gouged).7 of the 9 holes inspected were found conforming, 2 were not.There are burrs in the ends of the cutting slot.Device history record  (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required.The instrument was manufactured in may 2007, with a potential of 9 years in use.The most probable cause for deformation of the pin holes is normal wear and tear.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.

Event Description

It was reported that the pin holes on the guide were off, leading to pins becoming stuck in the guide.No procedure details were able to be provided where this issue may have occurred.Therefore, no patient consequences were reported as a result of the malfunction.

• Brand Name: NEXGEN 0 DEGREE RIGHT CUT GUIDE
• Type of Device: GUIDE, SURGICAL
• Manufacturer (Section D): ZIMMER INC.; 1800 west center street; po box 708; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7008103
• MDR Text Key: 92216204
• Report Number: 0001822565-2017-07557
• Device Sequence Number: 1
• Product Code: FZX
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2017
• 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: 00599707600
• Device Lot Number: 60723680
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2007
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1