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

Model Number N/A

Device Problems Device Stops Intermittently (1599); Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/28/2018

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

The customer reports that the product works intermittently (work 30 sec and stop).An intervention was scheduled to take skin from a deceased person but as the product did not work properly they could not do it.Then procedure was entirely on a deceased body.It took place before surgery.There was harm or injury as the product could not be used at all.No adverse events have been reported as a result of this malfunction.

Manufacturer Narrative

This event is recorded with zimmer biomet under (b)(4).On may 30, 2018, it was reported that the product works intermittently (work 30 sec and stop).An intervention was scheduled to take skin from a deceased person but as the product did not work properly they could not do it.The customer returned an electric dermatome device, serial number (b)(4), for evaluation.The device history record (dhr) reviewed 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.Medicrea has not previously repaired/evaluated electric dermatome serial number (b)(4) as documented in the repair reports in vdoc portal services.Product review of the electric dermatome by medicrea on july 3, 2018 revealed that the device control bar, thickness control shaft did not comply with the input test.It was also noted that the switch was damaged and the motor has no torque.The device calibration was out of specifications and the blade position was displaced.Repair of the electric dermatome was performed by medicrea on july 20, 2018 which included replacement of the bearings, motor, switch, control bar, and thickness control shaft.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 device control bar, thickness control shaft did not comply with the input test.It was also noted that the switch was damaged and the motor has no torque.The device calibration was out of specifications and the blade position was displaced.The cause of the reported event was due to malfunctioned and damaged parts.During the product review by medicrea it was noted that the device control bar, thickness control shaft did not comply with the input test.It was also noted that the switch was damaged and the motor has no torque.The device calibration was out of specifications and the blade position was displaced.It is unknown with the information that was provided how this occurred.Therefore, a root cause cannot be specifically determined with the provided information.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: 7561152
• MDR Text Key: 109800382
• Report Number: 0001526350-2018-00523
• 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: 07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• 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: 62600092
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2018
• Date Manufacturer Received: 07/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1