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

Model Number N/A

Device Problems Loss of Power (1475); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This event is recorded with zimmer biomet under (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Electr.Dermatom handpiece made ticking noise and then stopped working.Event occurred during surgery.Alternative device used to complete the surgery.No harm and no delay reported.There was no problem cause any impact/damage to graft harvest.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.On (b)(6) 2017, it was reported that the dermatome made ticking noise and then stopped working.The customer returned an electric dermatome device, serial number (b)(4), for evaluation.The device history record (dhr) review noted no related non-conformances, requests for deviation, change notices or any other issues with manufacturing or with the device.The dhr review also found that all verifications, inspections and tests were successfully completed.Zimmer biomet surgical has not previously repaired/evaluated electric dermatome serial number (b)(4) as documented in the repair reports in livelink.Product review of the electric dermatome by zimmer biomet australia on july 4, 2018 revealed that the technician conformed that the unit would intermittently not operate when triggered.It was also noted that the device motor speed and calibration were not with in specifications.Repair of the electric dermatome was performed by zimmer biomet taiwan on july 30, 2018 which included replacement of the motor, bearing pack, seal, reciprocating arm, 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 product review by zimmer biomet australia it was noted that the technician conformed that the unit would intermittently not operate when triggered.It was also noted that the device motor speed and calibration were not with in specifications.The root cause of the reported event could not be specifically determined with the information that was provided.During the product review by zimmer biomet australia it was noted that the technician conformed that the unit would intermittently not operate when triggered.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
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 7776466
• MDR Text Key: 116915582
• Report Number: 0001526350-2018-00610
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 08/28/2018

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: 00882100100
• Device Lot Number: 63138503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2018
• Initial Date Manufacturer Received: 07/04/2018
• Initial Date FDA Received: 08/13/2018
• Supplement Dates Manufacturer Received: 08/23/2018
• Supplement Dates FDA Received: 08/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1