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

Catalog Number 00770100000

Device Problem Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Date 06/10/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported the zimmer skin graft mesher was sent in for repair/maintenance and identified comb was bent.No patient involvement.No adverse events were reported as a result of this malfunction.

Event Description

No additional event information.

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 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 27 june 2019, it was reported that a mesher had a bent comb on (b)(6) 2019.The customer returned a zimmer skin graft mesher serial number: (b)(6) for evaluation.Evaluation of the device on 27 june 2019 and it was noted that the comb was bent.No further testing could be performed with the mesher due to the bent comb.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, 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.

• 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: 8760573
• MDR Text Key: 150289359
• Report Number: 0001526350-2019-00534
• 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: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• 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: 06/27/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1