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

Catalog Number 00770100000

Device Problem Failure to Cut (2587)

Patient Problem Abrasion (1689)

Event Date 06/08/2019

Event Type  Injury  

Manufacturer Narrative

This event is recorded by zimmer biomet under (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet.Once the product is returned and the investigation is complete, a follow up/final report will be submitted.

Event Description

The cutter did not cut the skin properly during surgery.There was a delay of about 1-15 minutes and an alternate device was not required to be used during the procedure.An additional graft was required from the patient.There was no reported issue with the mesher, but there was an issue reported on the cutter.No additional patient consequences were reported.

Event Description

No additional event information available.

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 reviews were unable to be performed as the device information pertaining to the mesher involved with the event was not provided when the event was reported nor was able to be acquired through follow-up.The reported event was confirmed by the service technician who performed the evaluation.On (b)(6) 2019, it was reported that a mesher was not cutting skin properly.The customer did not return the zimmer skin graft mesher that was involved with the event, but did return a 2:1 cutter serial number (b)(4) for evaluation.Evaluation of the cutter on 1 july 2019 noted that the cutter did not pass testing criteria and recommended that the cutter not be used and replaced.A quote for a new cutter was sent out and on 4 july 2019, the customer accepted the quote for a new cutter.The cutter was tested and inspected.While the service technician confirmed that the cutter did not pass testing criteria, indicating the cutter would not produce a proper mesh, it cannot be determined from the information provided as to what caused the cutter to fail.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, SURGICAL, SKIN GRAFT
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8788858
• MDR Text Key: 150968535
• Report Number: 0001526350-2019-00550
• Device Sequence Number: 1
• Product Code: FZW
• Combination Product (y/n): N
• PMA/PMN Number: PREAMEND
• 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: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00770100000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: ITEM: 00770302000 CUTTERSN: (B)(4) ; ITEM: 00770302000 CUTTERSN: (B)(4)
• Patient Outcome(s): Other