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

Catalog Number 00882100100

Device Problems Loss of Power (1475); Failure to Power Up (1476); Power Problem (3010)

Patient Problem No Code Available (3191)

Event Date 08/29/2019

Event Type  Injury  

Manufacturer Narrative

(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 device would turn on intermittently at first and then would no longer even turn on after a couple of attempts.It was "dragging and was very slow turning" when it did power on slightly.It would not remain on and after two attempts of barely running it did not turn back on again.It was not used on the patient, as this was simply during the testing phase prior to use.It was apparent from the test immediately that it could not be utilized.The patient was under anesthesia when this occurred.The delay was about 30-45 minutes before the surgeon decided to cancel.No additional consequences have been reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).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.The customer returned an electric dermatome device, serial number (b)(6), for evaluation.The customer also returned a power supply, serial number (b)(6) for evaluation.Product review of the electric dermatome on (b)(6) 2019 revealed that the calibration was out of specifications at the zero setting only.The motor did not run and the control bar was in the correct position.Repair of the electric dermatome was performed by zimmer biomet surgical on (b)(6) 2019 which included replacement of the plug harness assembly, o-ring, seal/strain relief, insulator, motor, switch, needle bearing, reciprocating arm, bearings, spring seal, ball plunger, semi-circle bearings, vespel bearings, and internal retaining ring.Electric dermatome, serial number (b)(6), was then tested and functioned properly.It was repaired, inspected and tested.While the returned product investigation confirmed that the electric dermatome was malfunctioning due to a failed motor, it cannot be determined from the information provided what actually caused the reported event.Therefore, based on the information provided, a specific root cause of the reported event 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.

Event Description

No additional information available.

• Brand Name: HANDPIECE, ELECTRIC DERMATOME
• Type of Device: DEROMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 9089306
• MDR Text Key: 160903193
• Report Number: 0001526350-2019-00799
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• 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: 61576460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization