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

Catalog Number 00882100100

Device Problem Electrical Shorting (2926)

Patient Problem No Patient Involvement (2645)

Event Date 08/06/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded under zimmer biomet complaint number (b)(4).The customer has indicated that the device is in process of being returned for evaluation and investigation is in process.Once the investigation is completed, a supplemental report will be filed accordingly.

Event Description

It was reported that the device was returned as a loan product belonging to zimmer biomet (b)(4), the cable is stripped.The customer did not indicate anything, the damage has been noticed by the after sales department.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).D4: (b)(4).Reported issue: on august 6, 2019, it was reported that after the loaner device was returned by the customer it was noticed by the zimmer biomet aftersales department that the cable was stripped.The customer returned an electric dermatome device, serial number (b)(4), for evaluation.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 august 22, 2019 revealed that the cable and switch were damaged.Repair of the electric dermatome was performed by flextronics on august 29, 2019 which included replacement of the plug harness assembly and switch.Electric dermatome, serial number (b)(4), 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 was damaged.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 (ie/capa/scar/hhe/d).This complaint will be tracked and trended for any adverse trends that may warrant further action.

Event Description

No additional event information was received.

• 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: 8922625
• MDR Text Key: 155267857
• Report Number: 0001526350-2019-00690
• 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: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• 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: 63791020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1