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

Model Number N/A

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

Patient Problem Unspecified Tissue Injury (4559)

Event Date 08/16/2023

Event Type  Injury  

Event Description

It was reported that during surgery the dermatome blade caused injury (deep cut to patient while shaving).There was no information regarding delay or intervention needed.An alternate device was available for immediate use.At investigation it was determined that the blade could have contributed to the issue.Due diligence is complete.No additional information is available.

Manufacturer Narrative

This event is recorded by zimmer biomet under (b)(4).Multiple mdr reports were filed for this event, please see associated reports: mfr - 0001526350-2023-01020-1 g2, country event occurred: new zealand.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The dhr was not reviewed as part and lot information is required and neither were provided.A definitive root cause cannot be determined.The event cannot be confirmed.A definitive root cause cannot be determined.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 BLADE
• 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: 18587075
• MDR Text Key: 333843401
• Report Number: 0001526350-2024-00149
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: N/A
• 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
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• 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: UNKNOWN BLADE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: CATALOG #00880300000DERMATOME SCREWDRIVER; CATALOG #:00880200100ZB DERMATOME 1" WIDTH PLATE; CATALOG #:00880200200ZB DERMATOME 2" WIDTH PLATE; CATALOG #:00880200300ZB DERMATOME 3" WIDTH PLATE; CATALOG #:00880200400ZB DERMATOME 4" WIDTH PLATE
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose