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

Catalog Number 00770100000

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The device history record and previous repair record for zimmer skin graft mesher serial number (b)(4) were reviewed and noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The record reviews found no issues with the device and all verifications, inspections, and tests were successfully completed.Using the machine-repair reports and the repair sites folders on livelink to query for all service on serial number(b)(4) prior to (b)(6) 2019, the device was noted to have been previously repaired twice, the last service being for calibration and repair reported on (b)(6) 2016.The reported event was confirmed by the service technician who performed the evaluation and repair of the device.On (b)(6) 2019, it was reported from (b)(6) medical centre that there was a defect with a skin graft mesher.The customer returned zimmer skin graft mesher serial number (b)(4) for evaluation.Evaluation of the device on (b)(6) 2019 and it was noted that there was a deformed comb and a broken gear on the device.Upon further evaluation, it was found that the mesher was out of calibration.The device still managed to produce a passing test mesh despite the bent comb and damaged gear.Repair of the mesher occurred on (b)(6) 2019 and involved replacing the comb, broken gear, spring seal, and multiple bearings as well as recalibrating the device.The technician then tested and verified that the mesher was functioning as intended and it was returned to the customer without further incident.The device was tested, inspected, and repaired.While the service technician found that there was a deformed comb and a broken gear on the mesher, both issues that would prevent the device from being operated as intended, it cannot be determined from the information provided as to what caused these failures with the device.Therefore, a specific root cause of the reported event cannot be determined.

Event Description

It was reported that the skin graft mesher was defected.There was no report of adverse event or delay in procedure as a result of this malfunction.An alternate device was available to complete the procedure.

• Brand Name: ZIMMER SKIN GRAFT MESHER
• Type of Device: SKIN GRAFT MESHER
• 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: 8846217
• MDR Text Key: 152946149
• Report Number: 0001526350-2019-00600
• Device Sequence Number: 1
• Product Code: FZW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 00770100000
• Device Lot Number: 61600227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2010
• 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