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 Known Impact Or Consequence To Patient (2692)

Event Date 07/14/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Evaluation and investigation is in process.Once the investigation is complete, a supplemental medwatch will be filed.

Event Description

It was reported that the device mesher cradle was bent and cutter was damaged.There was no harm and a delay reported.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.On (b)(6) 2019, it was reported that the device mesher cradle was bent and cutter was damaged.The customer returned a skin graft mesher device, serial number (b)(6), for evaluation.The customer also returned a 1:1 ratio cutter, serial number (b)(6) and a 1.5:1 ratio cutter, serial number (b)(6), for evaluation.The device history record (dhr) and previous repair report reviewed noted no related non-conformances, requests for deviation, change notices or any other issues with manufacturing or with the device.The dhr and previous repair report review also found that all verifications, inspections and tests were successfully completed.Zimmer biomet surgical has previously repaired/evaluated skin graft mesher serial number (b)(6) two times as documented in the repair reports in livelink.The last repair was november 30, 2017 where it was reported that the cradle was broken and the roller, bushings, wide plates, comb, shoulder bolts, and roller gear were replaced.This is not a related issue.Product review of the skin graft mesher on july 26, 2019 revealed that the calibration and sample mesh could not be taken due to the bent comb.The roller, roller gear, and side plates were visibly damaged.The 1:1 ratio cutter, serial number (b)(6) and 1.5:1 ratio cutter, serial number (b)(6) both produced an incomplete mesh and were deemed non-repairable.Repair of the skin graft mesher was performed by zimmer biomet surgical on july 26, 2019 which included replacement of the comb, gear, roller, side plates, and bearings.Skin graft mesher, serial number (b)(6), was then tested and functioned properly.It was repaired, inspected and tested.Although the reported event was confirmed during inspection of the device, it cannot be determined from the information provided what caused the components to fail.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.Review of the information provided during the investigation determined that there are no further actions needed at this time (ie/capa/scar/hhe/d).This complaint will be tracked and trended for any adverse trends that may warrant further action.

Event Description

No additional event information.

• 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
• MDR Report Key: 8835701
• MDR Text Key: 152521547
• Report Number: 0001526350-2019-00585
• Device Sequence Number: 1
• Product Code: FZW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• 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: 63007741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1