MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ZIMMER ELECTRIC DERMATOME HP; DERMATOME, LINE-POWERED

Model Number N/A

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Upon receipt of additional information, the product evaluation and the investigation is complete, a follow up/final report will be submitted.

Event Description

It was reported that device works intermittently and that power diminishes while in use.The event occurred before surgery and there was a delay of 16-30 (the minimal additional procedure time that is a customary amount of time for the access and exchange of a product or supply during a surgical procedure while the patient was under anesthesia).There was no harm reported to the patient as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.The following sections were updated: b4, d4, g4, g7, h2, h3, h4, h6, h8, h10.D4 - udi no.: (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.Product review of the electric dermatome by zimmer biomet on 09 december 2019 noted that the unit did not start, was out of calibration, the control bar position was not correct, the needle bearing and reciprocating arm were worn, the external e-rings were missing, the seal of the swivel as missing, the ball bearings were corroded and the ball plunged was damaged.Repair of the electric dermatome was performed by zimmer biomet which included replacement of the motor, sleeve, ball bearings, ball plunger, lever, shaft bearings, sleeve bearings, swivel, needle bearing, reciprocating arm, and external e-rings.Electric dermatome, serial number (b)(6)), was then tested and functioned properly.It was repaired, inspected and tested.Although the reported event was confirmed during inspection of the device, it cannot be determined from the information provided what caused the motor to fail.Therefore, the root cause could not be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Review of the information provided during the investigation determined that there are no further actions needed at this time.This complaint will be tracked and trended for any adverse trends that may warrant further action.

Event Description

No additional event information.

• Brand Name: ZIMMER ELECTRIC DERMATOME HP
• Type of Device: DERMATOME, LINE-POWERED
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 9385796
• MDR Text Key: 189631070
• Report Number: 0001526350-2019-01083
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/28/2020

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: Other
• Device Model Number: N/A
• Device Catalogue Number: 00882100100
• Device Lot Number: 63760533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/06/2019
• Initial Date FDA Received: 11/27/2019
• Supplement Dates Manufacturer Received: 01/21/2020
• Supplement Dates FDA Received: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1