MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ZIMMER SKIN GRAFT MESHER; EXPANDER, SURGICAL, SKIN GRAFT

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Failure to Cut (2587); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/09/2021

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined the unit failed the sample graft mesh test as the ratchet was stuck and would not rotate.The device was repaired and the reported issue was replaced.Device is used for treatment.A definitive root cause cannot be determined.The event is confirmed.

Event Description

It was reported that the graft board moves back and forth when passed through the meshgraft.The event occurred during surgery.There was no harm or delay and another device was used to complete the surgery.Investigation found the unit did not pass the mesh test due to the ratchet being stuck and unable to rotate.No adverse event was reported as a result of this malfunction.

• Brand Name: ZIMMER SKIN GRAFT MESHER
• Type of Device: EXPANDER, SURGICAL, SKIN GRAFT
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12632511
• MDR Text Key: 276404109
• Report Number: 0001526350-2021-01163
• Device Sequence Number: 1
• Product Code: FZW
• UDI-Device Identifier: 00889024375390
• UDI-Public: (01)00889024375390(11)190404(10)64371003
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• 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: 00770100000
• Device Lot Number: 64371003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1