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 Abrasion (1689)

Event Date 04/17/2023

Event Type  malfunction  

Manufacturer Narrative

This complaint is recorded by zimmer biomet under (b)(4).A follow up/ final report will be submitted once investigation is complete.

Event Description

It was reported from the surgeon that during surgery the graft that was taken was damaged, "striping the graft" where the graft started straight but at some point in the pass failed to cut cleanly.No harm or delay were initially reported.Diligence is in process and to date no new information has come in.

Event Description

There is no additional event information.

Manufacturer Narrative

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.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 h3 other text : not returned for evaluation.

• 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: 16919363
• MDR Text Key: 315092551
• Report Number: 0001526350-2023-00457
• Device Sequence Number: 1
• Product Code: GFD
• UDI-Device Identifier: 00889024380318
• UDI-Public: (01)00889024380318(17)260615(10)65159707
• 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
• Type of Report: Initial,Followup
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• 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: 65159707
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/24/2021
• 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
• Patient Outcome(s): Other
• Patient Sex: Female