MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. POWER SUPPLY, ELEC. DERMATOME; DERMATOME, PNEUMATICALLY-POWERED

Model Number N/A

Device Problem Intermittent Loss of Power (4016)

Patient Problem No Patient Involvement (2645)

Event Date 10/22/2019

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 the dermatome "works in chucks" , when connected to this power supply.Customer clarified "works in chucks" means that it does not function constantly but in frequencies (start- stop-start- stop).There were no exposed wires and the event timing was during the test of the power supply.There is no report of patient involvement, delay or harm as a result of this malfunction.

Event Description

No additional event information available.

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/corrected: b4, b5, d4, g4, g7, h2, h3, h4, h6, h10.Reported issue: on (b)(6) 2019, it was reported that the dermatome works in shocks, when connected to this power supply.Customer clarified, works in chucks, means that it does not function constantly but in frequencies of start- stop-start- stop.The customer returned an electric dermatome device, serial number, (b)(6), for evaluation.Dhr review: this investigation is being completed as a limited investigation as no problem was found with the device.Therefore the complaint history and dhr reviews are not required.Device evaluations results/investigation findings: product review of the electric dermatome by zimmer biomet on 21 november 2019 revealed that there was no problem with the unit and the device functioned as intended.Probable cause/root cause: the reported event was never confirmed during inspection of the device, and the device was noted to be functioning as intended.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.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.

• Brand Name: POWER SUPPLY, ELEC. DERMATOME
• Type of Device: DERMATOME, PNEUMATICALLY-POWERED
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 9440221
• MDR Text Key: 197754722
• Report Number: 0001526350-2019-01132
• 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: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00882100600
• Device Lot Number: 60604746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1