MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. HANDPIECE, ELECTRIC DERMATOME

Catalog Number 00882100100

Device Problem Loss of Power (1475)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

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

It was reported that the electric dermatome hand piece shut down while taking skin graft.An additional graft was required.

Event Description

It was reported that the electric dermatome hand piece shut down while taking skin graft.An additional graft was required.The patient was under anesthesia.The delay to get other hand pieces lasted roughly about 20 min.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.The device history record for zimmer electric dermatome serial number (b)(4) was reviewed noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The record review found no issues with the device and all verifications, inspections, and tests were successfully completed.Using the machine-repair reports and the repair sites folders on livelink as well as sap to query for all repairs on serial number (b)(4) prior to 13 february 2019, the device was noted to have not been previously repaired.The reported event was confirmed by the service technician who performed the evaluation and repair.On (b)(6) 2019, it was reported from (b)(6) that a dermatome shut down while taking a graft.Prior to taking the graft, the dermatome was also tested and was not turning on properly.The customer returned a zimmer electric dermatome, serial number (b)(4), for evaluation.Evaluation of the device on 5 march 2019 noted that the motor was running erratically and that side to side calibration was only out at the zero setting.Repair of the device occurred the same day and involved replacing the motor, power cord, power switch, and multiple bearings.The technician then tested and verified that the dermatome was functioning as intended and the device was returned to the customer without further incident.The device was tested, inspected, and repaired.Reference number (b)(4) on 13 february 2019.While the service technician found that the motor was running erratically, which would cause the device to not cut properly and appear as though it is turning on and off during use, it cannot be determined from the information provided as to what caused the motor to malfunction.Therefore, a specific root cause of the reported shutting down during use and not turning on properly cannot be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

• Brand Name: HANDPIECE, ELECTRIC DERMATOME
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8361798
• MDR Text Key: 136867591
• Report Number: 0001526350-2019-00123
• 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: consumer,user facility
• Type of Report: Initial,Followup
• Report Date: 03/27/2019

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: 63924234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/13/2019
• Initial Date FDA Received: 02/22/2019
• Supplement Dates Manufacturer Received: 03/27/2019
• Supplement Dates FDA Received: 03/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention