MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. HANDPIECE, ELECTRIC DERMATOME; DERMATOME, LINE-POWERED

Model Number N/A

Device Problem Material Frayed (1262)

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

Event Date 03/10/2022

Event Type  malfunction  

Event Description

It was reported that wires were exposed at base of handpiece.The event timing was after procedure.There was no harm or delay reported.No adverse events were reported as a result of this 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

There is no additional event information available.

Manufacturer Narrative

Review of the most recent repair record could not be completed because the device was not returned for evaluation and repair.It was noted that the device was last returned for repair or servicing in january 2013 and has not since been returned for annual preventative maintenance.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: HANDPIECE, ELECTRIC DERMATOME
• Type of Device: DERMATOME, LINE-POWERED
• 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: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13769750
• MDR Text Key: 287185706
• Report Number: 0001526350-2022-00231
• Device Sequence Number: 1
• Product Code: GFD
• 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: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Followup
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• 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: 00882100100
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2013
• 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