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

Catalog Number 00770100000

Device Problems Failure to Cut (2587); Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/20/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded under zimmer biomet complaint number (b)(4).The customer has indicated the device will be returned for evaluation and investigation is in process.Once the investigation is completed, a supplemental report will be filed accordingly.

Event Description

It was reported that the device was bent and dented outside and breaks the graft.No adverse events have been reported as a result of this malfunction.

Event Description

No additional event information available.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).D4: udi: (b)(4).The device history record and previous repair record for zimmer skin graft mesher serial number (b)(6) were reviewed and noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with the device.The record reviews found no issues with the device and all verifications, inspections, and tests were successfully completed.The reported event was confirmed by the service technician who performed the evaluation and repair.On (b)(6) 2019, it was reported that a mesher was bent and dented and would break grafts.The customer returned a zimmer skin graft mesher serial number (b)(6) as well as 1.5:1 cutter serial number (b)(6) and 2:1 cutter serial number (b)(6) for evaluation.Evaluation of the device on (b)(6) 2019 noted that the comb was bent on the device.None of the pretests could be performed due to the bent comb.The two cutters were reviewed and found to have produced passing cuts.Repair of the device occurred the same day and involved replacing the comb.The technician then tested and verified that the device was functioning as intended, then returned the device to the customer without further incident.The device was tested, inspected, and repaired.While the service technician found that the comb was bent, which can damage a graft during use of the mesher, it cannot be determined from the information provided as to what caused the comb to become bent.Therefore, the root cause of the reported event cannot 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.This complaint will be tracked and trended per complaint trending procedure for any adverse trends that may warrant further action.

Event Description

Additional event information received: since this mesher was being used between minor surgery clinic and or, the customer can't specifically confirmed the date that it happened.The customer checked with the surgeons whom they think have used it around that period and one of the nurse from msc but never got any detailed information about the problem.The customer noticed that the comb plate was bent and one of the metal thread on that comb plate was missing.No adverse events have been reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded under zimmer biomet complaint number (b)(4).The device has been returned for evaluation and investigation is in process.Once the investigation is completed, a supplemental report will be filed accordingly.

• Brand Name: ZIMMER SKIN GRAFT MESHER
• Type of Device: EXPANDER, SKIN GRAFT, SURGICAL
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8780199
• MDR Text Key: 150688471
• Report Number: 0001526350-2019-00546
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• 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: 64025402
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/11/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1