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

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

Patient Problem Laceration(s) (1946)

Event Date 10/04/2023

Event Type  Injury  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).G2 foreign: switzerland.Multiple mdr reports were filed for this event, please see associated report: 0001526350-2023-01350 evaluation and investigation is in process.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that during surgery the dermatome did not cut and prepare the skin properly.An additional skin graft was required from the patient with an unknown amount of delay to the procedure.Due diligence is complete as multiple attempts were made; however, no further information was received.As no additional information has been received, we are unable to provide further information.No additional consequences have been reported as a result of this malfunction.

Event Description

No additional event information available.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Review of the most recent repair record could not be completed because the device was not returned for evaluation and repair.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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.

• Brand Name: UNKNOWN DERMATOME
• 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: 17966258
• MDR Text Key: 326056926
• Report Number: 0001526350-2023-01348
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN DERMATOME BLADE.UNKNOWN LOT NUMBER.
• Patient Outcome(s): Required Intervention
• Patient Sex: Prefer Not To Disclose