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

Catalog Number 00770100000

Device Problems Device Damaged Prior to Use (2284); Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Date 07/09/2019

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 after test on the materials stored in the biomedical service, device was found with a damaged knife (cutter).The grill under the damaged knife, the lower roller, was deteriorated.No adverse events were reported as a result of this malfunction.

Event Description

It was reported that after test on the materials stored in the biomedical service, device was found with a damaged knife (cutter).Grill under the damaged knife and the lower roller were deteriorated.The biomedical technician request a repair.Per the investigation, it was discovered that the comb was bent.

Manufacturer Narrative

This event has been recorded by zimmer biomet under: (b)(4).This medwatch is being filed to relay additional information.The device history 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 review 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 12 july 2019, it was reported that a mesher had a damaged cutter, a damaged roller grate and a deteriorated roller.The customer returned a zimmer skin graft mesher serial number: (b)(6) for evaluation as well as 3:1 cutter serial number: (b)(6) for evaluation.Evaluation of the device on 23 august 2019 found that the returned cutter was damaged and that the comb on the mesher was bent.Despite finding the damaged comb and cutter, there was no failure noted with the roller and the device was able to produce a passing test mesh.The cutter was deemed non-repairable and was to be returned unrepaired.Repair of the mesher occurred the same day and involved replacing the comb.The technician then recalibrated the device and verified that it was functioning as intended.The mesher was then returned to the customer without further incident.The device was tested, inspected, and repaired.While the service technician confirmed that the comb was bent and the cutter was damaged, it cannot be determined from the information provided as to what caused the damage to either component.In addition, the service technician was unable to reproduce the reported roller damaged.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.

• 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: 8821277
• MDR Text Key: 152028715
• Report Number: 0001526350-2019-00572
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• 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: 33429700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1