MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. HANDPIECE, ELECTRIC DERMATOME

Model Number N/A

Device Problems Unstable (1667); Electrical Power Problem (2925); Noise, Audible (3273)

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

Event Date 11/30/2021

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4) once the investigation is completed, a follow-up/final report will be submitted.

Event Description

It was reported that during surgery the device was not operating at fast enough speed.There was no harm or serious injury reported.However there was a 20 minute delay where the patient was under anesthesia.No further adverse events were reported as it relates to this event.

Event Description

It was reported that during surgery the device would not run until placed on skin.At first it sounded like it was not running fast enough, so the blades were changed and then it sounded correct.The skin was placed on, and it changed back like it was not getting enough power.Different product was not used.There was no harm, and there was a 20 minute delay while patient was under anesthesia.There was no damage to the graft, and the graft was usable.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This complaints has been submitted under (b)(4).Review of the most recent repair record could not be completed because the device was not returned for evaluation and repair.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
• 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: 13087330
• MDR Text Key: 282781969
• Report Number: 0001526350-2021-01392
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• 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
• Device Lot Number: 31957600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/1999
• 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: IN: 00882100600,LOT 31203.
• Patient Age: 22 YR
• Patient Sex: Male