MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. DERMATOME BLADES

Model Number N/A

Device Problem Failure to Cut (2587)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/28/2023

Event Type  malfunction  

Manufacturer Narrative

An investigation into the reported event has been initiated under (b)(4).Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.

Event Description

It was reported that the surgeon using dermatome blade noticed that the skin graft harvest was unexpectedly non-uniform.The graft was successful nonetheless, but the product needed to be voluntarily reported.There was no harm or surgical delay reported.There are no adverse events associated with this malfunction.Due diligence is complete, there is no additional information available.

Manufacturer Narrative

The event has been recorded by zimmer biomet under (b)(4).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.The root cause of the reported issue is attributed to device design and manufacturing process.The event is 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.

Event Description

There is no additional information available.

• Brand Name: DERMATOME BLADES
• Type of Device: DERMATOME
• 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: 18152234
• MDR Text Key: 328315049
• Report Number: 0001526350-2023-01511
• Device Sequence Number: 1
• Product Code: GFD
• UDI-Device Identifier: 00889024375895
• UDI-Public: (01)00889024375895(17)280212(10)65647382
• 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: Other,Health Professional
• Reporter Occupation: Risk Manager
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00880000010
• Device Lot Number: 65647382
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/31/2023
• Initial Date FDA Received: 11/16/2023
• Supplement Dates Manufacturer Received: 04/22/2024
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2023
• 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
• Treatment: UNK ZIMMER DERMATOME.SN#: UNK.
• Patient Sex: Prefer Not To Disclose