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

Catalog Number 00882100100

Device Problem Output below Specifications (3004)

Patient Problem No Patient Involvement (2645)

Event Date 09/26/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Telephone number: (b)(6).The device history record (dhr) and previous repair report reviewed noted no related non-conformances, requests for deviation, change notices or any other issues with manufacturing or with the device.The dhr and previous repair report review also found that all verifications, inspections and tests were successfully completed.Product review of the electric dermatome by zimmer biomet (b)(4) on october 9, 2019 revealed that the device operated below motor speed specifications.The device was also outside calibration and side to side specifications.Repair of the electric dermatome was performed by zimmer biomet (b)(4) on october 11, 2019 which included replacement of the motor, switch, bearings, o-ring, seal, reciprocating arm and external e-ring.Electric dermatome, serial number (b)(4), was then tested and functioned properly.It was repaired, inspected and tested.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 (b)(4) it was noted that the device operated below motor speed specifications.The device was also outside calibration and side to side specifications.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.Review of the information provided during the investigation determined that there are no further actions needed at this time (ie/capa/scar/hhe/d).This complaint will be tracked and trended for any adverse trends that may warrant further action.

Event Description

This is a loaner device that was returned with no issues reported.During inspection of the device, it was discovered that it was operating below motor speed specifications.No adverse events were reported as a result of this malfunction.

• Brand Name: ZIMMER ELECTRIC DERMATOME HP
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 9571041
• MDR Text Key: 196083329
• Report Number: 0001526350-2020-00036
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00882100100
• Device Lot Number: 62812850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1