MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. DERMATOME BLADES; DERMATOME BLADE, SINGLE-USE

Model Number N/A

Device Problems Failure to Cut (2587); Patient Device Interaction Problem (4001)

Patient Problem Abrasion (1689)

Event Date 05/09/2023

Event Type  Injury  

Event Description

It was reported that dermatome blades damaged skin graft when taken during surgery.They tried four times changing blades and dermatome machine.They tried using blades with a different lot# with the same dermatome that caused the damaged graft and it worked therefore, they believe it was the dermatome blades with lot# 65531429 that was causing the problem.There was a surgical delay of 45 minutes.The harvest site did not need an unexpected medical intervention, such as sutures, however an additional unplanned skin graft was needed to complete the surgery.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

An investigation into the reported event has been initiated under cmp-0876874.Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.The following additional reports are being submitted in regards to (b)(4): 0001526350-2023-00522, 0001526350-2023-00524, 0001526350-2023-00525.

Event Description

There is no additional information available.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Visual examination of the provided picture identified the skin graft was incomplete at the center; the graft had a stripe of damage.However, the reported event cannot be confirmed as the product was not returned for evaluation and it cannot be confirmed this cutter produced the graft seen in the provided picture.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The event cannot be confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated report: 0001526350-2023-00522-1; 0001526350-2023-00524-1; 0001526350-2023-00525-1; h3 other text : product not returned.

• Brand Name: DERMATOME BLADES
• Type of Device: DERMATOME BLADE, SINGLE-USE
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17059401
• MDR Text Key: 316513732
• Report Number: 0001526350-2023-00523
• Device Sequence Number: 1
• Product Code: GFD
• UDI-Device Identifier: 00889024375895
• UDI-Public: (01)00889024375895(17)270706(10)65531429
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00880000010
• Device Lot Number: 65531429
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose