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

Catalog Number 00770100000

Device Problem Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Date 05/12/2019

Event Type  malfunction  

Manufacturer Narrative

This event is recorded by zimmer biomet under (b)(4).Once the investigation is complete, a follow up/final report will be submitted.

Event Description

It was reported that there was a repair requested since the comb of the device was found to be damaged during cleaning.There was no harm or delay involved and there was no patient involvement.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded under zimmer biomet complaint number (b)(4).This report is being filed to relay additional information.

Event Description

No additional event information available.

Manufacturer Narrative

This event is 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 manufacturing.The record review found no issues with the device and all verifications, inspections, and tests were successfully completed.Using the machine-repair reports and the repair sites folders on livelink to query for all repairs on serial number (b)(6) prior to 13 may 2019, the device was noted to have not been previously repaired.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 evaluated and repaired the device.On 13 may 2019, it was reported that a mesher had a damaged comb.The customer returned a zimmer skin graft mesher serial number (b)(6) for evaluation.Evaluation of the device noted that the device had a damaged comb.Repair of the device occurred on 15 may 2019 and involved replacing the damaged comb as well as recalibrating the device.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 confirmed that the comb was damaged, 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 complaint trending procedure for any adverse trends that may warrant further action.

Event Description

No additional information available.

• Brand Name: ZIMMER SKIN GRAFT MESHER
• Type of Device: SKIN GRAFT MESHER
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8767689
• MDR Text Key: 150274266
• Report Number: 0001526350-2019-00537
• 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,Followup
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• 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: 62195870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1