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

Catalog Number 00770100000

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2019

Event Type  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.

Event Description

It was reported that the device had difficulty with ratchet in use.The issue occurred prior to surgery: subsequently, this caused no patient harm, and there was no delay.No adverse events have been reported as a result of this malfunction.

Event Description

No additional event information was received.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.G4: (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.On 2 july 2019, it was reported that it was difficult to use a ratchet with a mesher.The customer returned a zimmer skin graft mesher serial number (b)(6) for evaluation.Evaluation of the device on 2 july 2012 and it was noted that the comb was bent on the device, but that the ratchet attached and functioned as intended.Repair of the mesher occurred on 3 july 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.Reference number (b)(4) on 2 july 2019.The service technician was unable to reproduce the reported event with the device.As such, a specific 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, SKIN GRAFT, SURGICAL
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8802789
• MDR Text Key: 151461555
• Report Number: 0001526350-2019-00561
• 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: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• 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: 63704638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1