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 Laceration(s) (1946)

Event Date 07/13/2023

Event Type  Injury  

Manufacturer Narrative

This complaint is recorded by zimmer biomet under (b)(4).No product was returned.A picture was provided of a harvest site with the middle missing.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The root cause of the reported issue is attributed to a manufacturing and design issue.The event is confirmed for the blades.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 reports: 0001526350-2023-00906-1, 0001526350-2023-00907-1, 0001526350-2024-00076, and 0001526350-2024-00077.

Event Description

It was reported that during surgery while the surgeon was harvesting the skin from the patient's upper thigh, some of the harvest skin was removed appropriately in one full piece.However, other harvest pieces, the skin was ragged on the edge and some skin was missing from the middle of the harvest site.New dermatome blades were used and had the same result.A new dermatome was opened and had similar results.Mineral oil was used over the patient's skin for each pass of the dermatome.There was no noted harm to the patient and sutures were not required.There was a delay of 5-10 minutes while staff were getting additional blades and dermatome.Some of the taken grafts were used, while other strips were too small to be used.Additional grafts were taken until enough was harvested to cover the site.During investigation it was determined that the blade is related to the reported event.Due diligence is complete and there is no additional information available.

• 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: 18503153
• MDR Text Key: 332781360
• Report Number: 0001526350-2024-00075
• Device Sequence Number: 1
• Product Code: GFD
• UDI-Device Identifier: 00889024375895
• UDI-Public: (01)00889024375895(17)280213(10)65648460
• 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: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• 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: 65648460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: ZFA 2023-00208
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female