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

Model Number N/A

Device Problems Failure to Cut (2587); Output Problem (3005)

Patient Problem Laceration(s) (1946)

Event Date 08/14/2020

Event Type  Injury  

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 the device cut too deep during surgery.Patient harm occurred, medical intervention and additional procedure was required.The patient was under anesthesia during the 30 min delay caused by the device.Patient needed additional sutures as a result.No additional adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Review of the most recent repair record determined the calibration was out at the 0 reading and lever was loose so the device was re-calibrated and bearings were replaced and resolved the reported issue.Review of the previous repair record identified unrelated repairs to the reported event.The device was tested and found to be functioning to specifications prior to release to the customer.Device is used for treatment.A definitive root cause cannot be determined.The event cannot be confirmed.

Event Description

There is no additional information.

• Brand Name: ZIMMER AIR DERMATOME
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 10441868
• MDR Text Key: 203996210
• Report Number: 0001526350-2020-00708
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• 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: 61296353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other