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 Date 06/13/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet.Once the product is returned and the investigation is complete, a follow up/final report will be submitted.

Event Description

It was reported that the unit comb was damaged.The event occurred during surgery.There was no harm and no delay involved, and an alternate device was used for the surgery.No adverse events were reported as a result of this malfunction.

Event Description

No additional information available.

Manufacturer Narrative

This event is recorded by zimmer biomet under (b)(4).The following sections were updated/corrected: d4 - udi# - (b)(4).On june 20, 2019, it was reported that the unit comb was damaged.The customer returned a skin graft mesher device, serial number (b)(4), 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)(4) four times as documented in the repair reports in livelink.The last repair was january 22, 2019 where it was reported that the device had a damaged comb and the comb shaft, shoulder bolts, and comb were replaced.This is a related issue.On june 20, 2019, it was reported that the unit comb was damaged.The customer returned a skin graft mesher device, serial number (b)(4), for evaluation.Product review of the skin graft mesher on july 9, 2019 revealed that the calibration and sample mesh could not be taken due to the bent comb.No ratchet or cutters were returned for evaluation.Repair of the skin graft mesher was performed by zimmer biomet surgical on july 9, 2019 which included replacement of the comb.Skin graft mesher, serial number (b)(4), was then tested and functioned properly.It was repaired, inspected and tested.While the returned product investigation confirmed that the skin graft mesher had a damaged comb, it cannot be determined from the information provided what actually caused the reported event.Therefore, based on the information provided, a specific root cause of the reported event cannot be determined.The device was noted to be functioning as intended after the comb was replaced.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

• 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
• MDR Report Key: 8754923
• MDR Text Key: 149852807
• Report Number: 0001526350-2019-00523
• 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: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• 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: 63618564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1