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 08/08/2023

Event Type  Injury  

Manufacturer Narrative

This event is recorded with zimmer biomet under (b)(4).This medwatch is being filed as an initial report.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.H3 other text : device not yet returned.

Event Description

It was reported that the device went thru multiple blades while attempting to harvest a skin graft but was unable to get a fully intact graft.The event occurred during surgery on (b)(6) 2023.There was a reported patient harm, and an unknown delay.Due diligence is in progress, no further information is available at this time.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.No product was returned or pictures provided; functional, visual, and/or 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 a manufacturing issue.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.

Event Description

No additional event 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: 17690021
• MDR Text Key: 322722556
• Report Number: 0001526350-2023-01078
• Device Sequence Number: 1
• Product Code: GFD
• UDI-Device Identifier: 00889024375895
• UDI-Public: (01)00889024375895(17)280220(10)65925348
• 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,Followup
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2023
• 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: 65925348
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2023
• 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): Other
• Patient Sex: Prefer Not To Disclose