MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ZMR ELECTR. DERMATOM HANDPIECE; DERMATOME, LINE-POWERED

Catalog Number 00882100100

Device Problem Loss of Power (1475)

Patient Problems Abrasion (1689); No Code Available (3191)

Event Date 09/16/2018

Event Type  malfunction  

Manufacturer Narrative

This event is recorded by zimmer biomet under (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet.Once the product is returned and the investigation is complete, a follow up/final report will be submitted.

Event Description

Electric dermatome handpiece had loss of power during case.There was a delay associated with the event but the delay time was unknown.No adverse events were reported as a result of this malfunction.

Event Description

Electric dermatome handpiece had loss of power during case.There was a 10-15 minute delay associated with the event but there was no alternate device used for the procedure because it was not available.The same device was used after turning it off and letting it sit for sometime.The surgeon then turned on the device successfully and there was enough power to get a second strip of tissue.No additional patient consequences were reported as a result of this malfunction.

Manufacturer Narrative

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

Event Description

No additional event information.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).On september 18, 2018, it was reported that there was a loss of power during case.The customer returned an electric dermatome device, serial number (b)(4), for evaluation.The customer also returned a power supply, serial number (b)(4), for evaluation.The device history record (dhr) and previous repair report of electric dermatome serial number (b)(4) reviewed noted no related non-conformances, requests for deviation, change notices or any other issues with manufacturing or with the device.The dhr and previous repair report review also found that all verifications, inspections and tests were successfully completed.Zimmer biomet surgical has previously repaired/evaluated electric dermatome serial number (b)(4) one time as documented in the repair reports in livelink.The last repair was march 1, 2018 where it was reported that the device was sent in as part of the 2012 skin graft initiative and the power cord assembly, power switch, ball detent, thickness lever, reciprocating arm, bearings, seal and retaining ring, motor, and o-ring were replaced.This is not a related issue.The device history record (dhr) and previous repair report of electric dermatome power supply serial number (b)(4) reviewed noted no related non-conformances, requests for deviation, change notices or any other issues with manufacturing or with the device.The dhr and previous repair report review also found that all verifications, inspections and tests were successfully completed.Zimmer biomet surgical has previously repaired/evaluated electric dermatome power supply serial number (b)(4) one time as documented in the repair reports in livelink.The last repair was february 22, 2018 where it was reported that the device was sent in as part of the 2012 skin graft initiative and the device was evaluated with no components replaced.This is not a related issue.Zimmer biomet surgical has previously repaired/evaluated electric dermatome power supply serial number (b)(4) one time as documented in the repair reports in livelink.The last repair was february 22, 2018 where it was reported that the device was sent in as part of the 2012 skin graft initiative and the device was evaluated with no components replaced.This is not a related issue.Product review of the electric dermatome on september 27, 2018 revealed that the calibration was out of specifications at the zero setting only.The motor speed was out of specifications on the high side and the control bar was in the correct position.Product review of the electric dermatome power supply on september 26, 2018 revealed that the device functioned as intended and passed all required testing.Repair of the electric dermatome was performed by zimmer biomet surgical on september 27, 2018 which included replacement of the power cord assembly, power switch, bearings, seal and retaining ring, motor, and o-ring.Electric dermatome, serial number (b)(4), was then tested and functioned properly.It was repaired, inspected and tested.The reported event was confirmed since during the product review it was noted that the motor speed was out of specifications on the high side.The root cause of the reported event could not be specifically determined with the information that was provided.During the product review it was noted that the motor speed was out of specifications on the high side.It is unknown with the information that was provided how this occurred.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

• Brand Name: ZMR ELECTR. DERMATOM HANDPIECE
• Type of Device: DERMATOME, LINE-POWERED
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 7907319
• MDR Text Key: 121646678
• Report Number: 0001526350-2018-00898
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00882100100
• Device Lot Number: 61896868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/18/2018
• Initial Date FDA Received: 09/25/2018
• Supplement Dates Manufacturer Received: 10/31/2018; 11/06/2018
• Supplement Dates FDA Received: 11/01/2018; 11/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 59