MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ZIMMER DERMATOME 1" WIDTH PLATE

Model Number N/A

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2023

Event Type  malfunction  

Event Description

It was reported that during preventative maintenance the width plates are damaged.There was no patient involvement.Due diligence is complete and there is no additional information available.There was no adverse event associated with the malfunction.

Manufacturer Narrative

An investigation into the reported event has been initiated under (b)(4).Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.Multiple mdr reports were filed for this event, please see associated reports: 0001526350-2024-00093; 0001526350-2024-00094.E1 telephone number: (b)(6).G2 country: united kingdom.

• Brand Name: ZIMMER DERMATOME 1" WIDTH PLATE
• 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: 18527092
• MDR Text Key: 333044719
• Report Number: 0001526350-2024-00092
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00880200100
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: No
• 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: 00880100100ZIMMER AIR DERMATOMESN (B)(6)
• Patient Sex: Prefer Not To Disclose