MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN REVISION BLOCK CUTTER; GUIDE, SURGICAL, INSTRUMENT

Model Number N/A

Device Problems Mechanical Jam (2983); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Concomitant medical product: unknown drill bit, catalog#: unknown lot#: unknown.The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch 3500a will be submitted.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: 0001822565-2018-00166, 0001822565-2018-00167.

Event Description

It was reported that the drill bit broke off in the tibial cutting block.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

The complaint sample was evaluated and the reported event was confirmed through physical evaluation.The returned block cutter showed signs of repeated use (nicked, gouged, burrs) and the fractured piece of the drill bit was confirmed to be stuck in the drill guide hole.No further evaluation of the fractured drill bit could be performed, as it could not be removed from the guide and only the fractured portion of the drill bit was returned.Hardness testing identified that the guide was within specification.The device history records were reviewed and no discrepancies relevant to the reported event were identified.A definitive root cause could not 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.

• Brand Name: NEXGEN REVISION BLOCK CUTTER
• Type of Device: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7174968
• MDR Text Key: 96736760
• Report Number: 0001822565-2018-00166
• Device Sequence Number: 1
• Product Code: FZX
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00598703301
• Device Lot Number: 61323033
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/21/2017
• Date Manufacturer Received: 06/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1