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

Catalog Number 00770100000

Device Problem Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Type  Injury  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Upon investigation it was found the device had a previously reported malfunction.This medwatch is being filed to relay the investigation evaluation.The device history record (dhr) review noted no related non-conformance, requests for deviation, change notices or any other issues with manufacturing or with the device.The dhr review also found that all verification, inspections and tests were successfully completed.Zimmer biomet surgical has not previously repaired/evaluated skin graft mesher serial number (b)(4) as documented in the repair reports in (b)(4).On (b)(6) 2019, it was reported that the pin in the mesher was bent.The customer returned a skin graft mesher device, serial number (b)(4) , for evaluation.Product review of the skin graft mesher on june 19, 2019 revealed that the comb was bent.The ratchet gear, pin, and spring were all worn and needed replaced.The calibration and sample mesh could not be taken due to the bent comb.No cutters were returned for evaluation.Repair of the skin graft mesher was performed by zimmer biomet surgical on june 19, 2019 which included replacement of the ratchet gear, ratchet spring, ratchet sliding pin, and comb.Skin graft mesher, serial number (b)(4) , was then tested and functioned properly.It was repaired, inspected and tested.Although the reported event was confirmed during inspection of the device, and the device was found to be functioning as intended after the repair was completed, it cannot be determined from the information provided what caused the reported event.Therefore, the root cause could not be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

Event Description

It was reported that the pin in the mesher was bent.The mesher was not used on a patient.

• 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: 8824065
• MDR Text Key: 152118122
• Report Number: 0001526350-2019-00578
• Device Sequence Number: 1
• Product Code: FZW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00770100000
• Device Lot Number: 62059009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2012
• 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