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

Model Number N/A

Device Problem Fitting Problem (2183)

Patient Problem No Patient Involvement (2645)

Event Date 05/04/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the dermatome handpiece and hose unable to fit in properly.Yearly calibration.Event did not occur during surgery, no patient involvement.No adverse events were reported as a result of this malfunction.

Event Description

No additional event information available.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Product review of the zimmer air dermatome serial number (b)(6) by zimmer - taiwan on 08 may 2020 revealed that the motor, handpiece switch, bearings, o-ring, seal, and reciprocating arm needed to be replaced.Repair of the device was performed by zimmer - taiwan on 08 may 2020 which included replacement of the following: motor: pn r6-0018-103-53, ln 64399402, motor sleeve: pn r6-0018-103-78, ln 64240794, ball bearing: pn r6-0018-103-81, ln 64434874, spring seal: pn r6-0018-103-82, ln 64434875, needle bearing: pn r6-0018-103-93, ln 64422165, o-ring: pn r6-0018-105-41, ln 64123935, reciprocating arm: pn r6-0018-106-57, ln 64434881, the device, serial number (b)(6) , was then tested and functioned properly.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
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 10086708
• MDR Text Key: 192053335
• Report Number: 0001526350-2020-00469
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 00880100100
• Device Lot Number: 63138619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/05/2020
• Initial Date FDA Received: 05/26/2020
• Supplement Dates Manufacturer Received: 09/03/2020
• Supplement Dates FDA Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1