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

Catalog Number 00882100100

Device Problem Circuit Failure (1089)

Patient Problem No Patient Involvement (2645)

Event Date 07/23/2019

Event Type  malfunction  

Manufacturer Narrative

The event recorded by zimmer biomet under (b)(4).Customer has indicated that product is in the process of being returned to zimmer biomet for investigation.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported that the electric dermatome cable is detached from the connector.The event occurred during a kit inspection.No patient involvement.No harm to patient or operator.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Dhr review: 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.Device evaluations results/investigation findings: product review of the electric dermatome by flextronics on july 31, 2019 revealed that the cable, strain relief, compression cap and washer were missing.The motor was corroded and the machine head was damaged.The lever, screws and needle bearing were also damaged.The reciprocating arm and eccentric shaft were corroded.Repair of the electric dermatome was performed by flextronics on september 5, 2019 which included replacement of the washers, strain relief, motor, motor seal, compression cap, plug harness assembly, sleeve bearings, shaft bearings, machine head, screws, lever, fine adjustment cams, ball plunger, eccentric shaft, reciprocating arm and needle bearing.Electric dermatome, serial number (b)(6), was then tested and functioned properly.It was repaired, inspected and tested.Probable cause/root cause: the root cause of the reported event could not be specifically determined with the information that was provided.During the product review by flextronics it was noted that the cable, strain relief, compression cap and washer were missing.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.Conclusion: 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 is available.

• Brand Name: ZIMMER ELECTRIC DERMATOME HP
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8851501
• MDR Text Key: 153075269
• Report Number: 0001526350-2019-00606
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• 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: 60287875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1