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

Catalog Number 00770100000

Device Problem Failure to Cut (2587)

Patient Problem No Patient Involvement (2645)

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 had incomplete mesh.This occurred during meshing of previously recovered cadaver skin.There was no harm/injury involved and there was no patient involvement.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 upon investigation completion as final.On june 17, 2019, it was reported that the unit produced an incomplete mesh.The customer returned a skin graft mesher device, serial number: (b)(6), for evaluation.The customer also returned an autoclave case, ratchet, 1.5:1 ratio cutter, serial number: (b)(6), and a 2:1 ratio cutter, serial number: (b)(6), for evaluation.Device evaluations results/investigation findings: product review of the skin graft mesher on june 26, 2019 revealed that the calibration was slightly out of specifications but the mesher produced a complete cut with the qa test cutter.The gear had visible damage.The 1.5:1 ratio cutter, serial number: (b)(6) and 2:1 ratio cutter, serial number: (b)(6), both produced incomplete cuts after the collars and gears were replaced and were deemed non-repairable.Repair of the skin graft mesher was performed by zimmer biomet surgical on june 26, 2019 which included replacement of the roller gear.Skin graft mesher, serial number: (b)(6), was then tested and functioned properly.It was repaired, inspected and tested.Probable cause/root cause: the cause of the reported event was due to the defective 1.5:1 and 2:1 ratio cutters.During the product review it was noted that the 1.5:1 ratio cutter, serial number: (b)(6) and 2:1 ratio cutter, serial number: (b)(6), both produced incomplete cuts after the collars and gears were replaced and were deemed non-repairable.It is unknown with the information that was provided how this occurred.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

Event Description

No additional event information available.

• 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: 8755404
• MDR Text Key: 149856168
• Report Number: 0001526350-2019-00525
• 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: 10/29/2019

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: 63138572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1