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

Catalog Number 00770100000

Device Problem Failure to Cut (2587)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 06/27/2018

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow up mdr will be submitted.

Event Description

It was reported that the device had incomplete mesh.No adverse events were reported as a result of this malfunction.

Event Description

No additional event information was received.

Manufacturer Narrative

This event has been recorded by zimmer biomet under: (b)(4).This medwatch is being filed to relay additional information.Reported issue: on july 13, 2018, it was reported that the device produced an incomplete mesh.The customer returned a skin graft mesher device, serial number: (b)(6), for evaluation.The customer also returned a 1.5:1 ratio cutter, serial number: (b)(6), and a 2:1 ratio cutter, serial number: (b)(6), for evaluation.Dhr review: 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) thirty eight as documented in the repair reports in livelink.The last repair was may 14, 2018 where it was reported that the device produced an incomplete mesh and was calibrated to specifications.This is not a related issue.Zimmer biomet surgical has previously repaired/evaluated skin graft mesher 1.5:1 ratio cutter serial number: (b)(6) four times as documented in the repair reports in livelink.The last evaluation was may 14, 2018 where it was found that the device produced an incomplete cut and was deemed non-repairable.Zimmer biomet surgical has previously repaired/evaluated skin graft mesher 2:1 ratio cutter serial number: (b)(6) four times as documented in the repair reports in livelink.The last evaluation was may 14, 2018 where it was found that the device produced an incomplete cut and was deemed non-repairable.Of the 5 complaints, 1 was the reported event while the other 4 appeared to be related to an incomplete mesh.All 5 complaints were from the same account the living legacy foundation.No additional action is required at this time.Device evaluations results/investigation findings: product review of the skin graft mesher on july 24, 2018 revealed that the carrier guide and roller gear were damaged.The device was within calibration specifications and produced a passing sample mesh.The device came in with two cutters; 1.5:1 ratio cutter, serial number: (b)(6), and 2:1 ratio cutter, serial number: (b)(6), which both produced an incomplete cut and were deemed non-repairable.Repair of the skin graft mesher was performed by zimmer biomet surgical on july 24, 2018 which included replacement of the carrier guide and 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 using cutters that had been previously repaired defective and non-repairable.During the current and previous repair 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 an incomplete cut 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.Conclusion: 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

It was reported that the device had incomplete mesh.The event took place during meshing of previously recovered cadaver skin.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.The product has been returned to zimmer biomet for investigation.Once the investigation has been completed, a follow up mdr will be submitted.

• 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: 8838395
• MDR Text Key: 152945970
• Report Number: 0001526350-2019-00591
• 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,Followup
• Report Date: 09/27/2019

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: 60461116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1