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

Catalog Number 00880100100

Device Problems Failure to Cut (2587); Noise, Audible (3273); Patient Device Interaction Problem (4001)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 03/13/2020

Event Type  Injury  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Once an investigation is completed, a follow-up/final report will be submitted.(b)(6).

Event Description

It was reported that the device was rattling and making an abnormal noise.The surgeon also mentioned the device was not cutting correctly.There was a 0-15 minute delay reported and there was an impact to the graft, though the impact was not clarified any further.No adverse events were 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.The following sections were updated/corrected: b4, b5, d4, g4, g7, h2, h3, h4, h6, h8, h10.The patient's graft was impacted; however, the extent of the impact is unknown.Current repair: product evaluation: product review of the air dermatome serial number (b)(6) by zimmer-taiwan on 6 april 2020 revealed that the oscillator bearing is missing, oscillator pin is damaged, head worn, and width plate 4in is worn.Product repair of the device was performed by zimmer-taiwan on 6 april 2020 which included replacement of the following: motor (pnr6001810353, ln64399042), ball bearing (pnr6001810381, ln64434894), spring seal (pnr6001810382, ln64434895), needle bearing (pnr6001810393, ln64581592), reciprocating arm (pnr6001810657, ln64434881), motor sleeve (pnr6001810378, ln64240994), o-ring (pnr6001810541, ln64123935) the device, serial number 113442, was then tested and functioned properly.It was repaired, inspected and tested.Review of the device history records identified no deviations or anomalies during manufacturing.Device is used for treatment.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The event is not confirmed.

• 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: 9904163
• MDR Text Key: 186582076
• Report Number: 0001526350-2020-00333
• 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: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00880100100
• Device Lot Number: 63862472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other