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

Model Number N/A

Device Problems Failure to Cut (2587); Material Twisted/Bent (2981); Patient Device Interaction Problem (4001)

Patient Problems Laceration(s) (1946); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

It was reported that during surgery on an unknown date, the blades were producing variable thickness grafts.It was also reported that all of the hospital's dermatome kits were old and none of them were being serviced/maintained.There is no additional information regarding if the patient's were harmed, if additional grafts were taken or if there was delay in the procedures.It is unknown how many surgeries took place and when they took place.Due diligence is in process and there is no additional information available.

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.E1 telephone number: (b)(6).G2 country: united kingdom.

Manufacturer Narrative

This complaint is recorded by zimmer biomet 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.Multiple mdr reports were filed for this event, please see associated reports: 0001526350-2023-01485.

Event Description

It was reported that during surgery the blades were producing variable thickness grafts and the blade appeared to be bent.The taken graft was damaged as the central piece of skin was missing in the graft, leaving only two small strips.An additional graft was taken which led to a larger donor site wound on the patient's thigh.There was no delay noted in the procedure.Due diligence is complete and there is no additional information available.

Manufacturer Narrative

This mdr is a duplicate of 0001526350-2023-01153.The initial report was created in error and should be voided.

Event Description

This mdr is a duplicate of 0001526350-2023-01153.The initial report was created in error and should be voided.

• 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: 17788438
• MDR Text Key: 323922366
• Report Number: 0001526350-2023-01170
• Device Sequence Number: 1
• Product Code: GFD
• UDI-Device Identifier: 00889024375895
• UDI-Public: (01)00889024375895(17)280214(10)65709066
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2023
• 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: 65709066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2023
• 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 DERMATOME.
• Patient Outcome(s): Required Intervention
• Patient Sex: Prefer Not To Disclose