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

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  

Manufacturer Narrative

This event is recorded by zimmer biomet under (b)(4).G2, country event occurred: new zealand.The product is in the process of being evaluated by zimmer biomet.Once the product investigation has been completed, a follow up/final report will be submitted.

Event Description

It was reported that during surgery the dermatome blade caused injury during surgery (deep cut to patient while shaving).There was no information regarding harm, injury or delay.An alternate device was available for immediate use.Due diligence is complete.No additional information is available.

Event Description

No additional information is available regarding the incident.

Manufacturer Narrative

This event is recorded by zimmer biomet under cmp-(b)(4).Multiple mdr reports were filed for this event, please see associated reports: mfr - 0001526350-2024-00149.The following sections have been updated: b4, b5, d2, d4, d9, g1, g3, g6, h1, h2, h3, h4, h6, h10.Review of the most recent repair record determined the reported issue could not be duplicated.The control bar had slight movement and various parts were worn.The motor, needle bearing, shaft and sleeve bearings, swivel, hinge gasket, spring seal, and reciprocating arm were replaced.Review of the device history record identified no deviations or anomalies during manufacturing.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: ZIMMER AIR 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: 17728165
• MDR Text Key: 323157181
• Report Number: 0001526350-2023-01020
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2023
• 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: 00880100100
• Device Lot Number: 62244209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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
• Date Device Manufactured: 12/18/2012
• 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: CATALOG #: 00880200100.; CATALOG #: 00880200200.; CATALOG #: 00880200300.; CATALOG #: 00880200400.
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose