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

Catalog Number 00770100000

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

Patient Problem No Patient Involvement (2645)

Event Date 06/06/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The product has been 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 during kit inspection, it was found that the device would not cut well and that the comb was damaged.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The device history record for zimmer skin graft mesher serial number (b)(6) was 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.Review of the complaint history based on the above keywords found no other similar events related to the reported device; as such, no further additional action is required at this time.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 had a deformed part.The customer returned a zimmer skin graft mesher serial number (b)(6) for evaluation.Evaluation of the device found that the comb was bent.Repair of the mesher occurred on (b)(6) 2019 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, 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

No additional event information was received.

• 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: 8775780
• MDR Text Key: 150549479
• Report Number: 0001526350-2019-00543
• 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
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• 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: 31608900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1