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

Model Number N/A

Device Problem Failure to Cut (2587)

Patient Problem No Patient Involvement (2645)

Event Date 06/29/2020

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).

Event Description

It was reported by the hospitals engineering department that the device is not working properly.No patient involvement.The instrument doesn't cut sideways.The event occurred at the engineering department during inspection.There was no adverse event reported as a result of this malfunction.

Event Description

There is no additional information.

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 motor was malfunctioning, the unit was out of calibration, the reciprocating arm was worn, and the machine head and control bar were damaged.The motor, reciprocating arm, machined head, and control bar were replaced and resolved the reported issue.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Device is used for treatment.A definitive root cause cannot be determined.The event is confirmed.

• Brand Name: ZIMMER AIR DERMATOME COMPLETE
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 10475844
• MDR Text Key: 205118792
• Report Number: 0001526350-2020-00739
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• 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: 00880100000
• Device Lot Number: 60275786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1