MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. POWER SUPPLY, ELEC. DERMATOME

Model Number N/A

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/07/2018

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The product has been returned to zimmer biomet for investigation.Once the investigation has been completed, a follow up mdr will be submitted.

Event Description

It was reported that unit's power to hand piece fluctuates intermittently.Event occurred during surgery.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This follow up report is being submitted to report to additional information the following sections were updated.On (b)(6) 2018, it was reported that the unit's power to hand piece fluctuates intermittently.The customer returned an electric dermatome power supply, serial number (b)(4), for evaluation.The device history record (dhr) review was not performed since this investigation falls within the scope of icwr008 (limited investigation) as the device functioned as intended and there were no faults found during initial inspection.Zimmer biomet surgical has previously repaired/evaluated electric dermatome power supply serial number (b)(4) one time as documented in the repair reports.The last repair was october 17, 2017 where it was reported that the device needed preventative maintenance and the device was evaluated with no components replaced.This is not a related issue.Product review of the electric dermatome power supply on (b)(6) 2018 revealed that the voltage did not fluctuate during testing.There were no repairs required.The electric dermatome power supply was not repaired as the device functioned as intended and passed all required testing.It was inspected and tested.The reported event was not confirmed since the device functioned as intended.The reported event was not confirmed since the device functioned as intended during initial inspection; hence, a root cause cannot be determined.There were no other issues with the device.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

Event Description

It was reported that unit's power to hand piece fluctuates intermittently.Event occurred during surgery.No harm reported and alternative device was used for the procedure.No delays.

• Brand Name: POWER SUPPLY, ELEC. DERMATOME
• 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: 7659488
• MDR Text Key: 113194225
• Report Number: 0001526350-2018-00597
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/17/2018

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00882100600
• Device Lot Number: 63394133
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/11/2018
• Initial Date FDA Received: 07/03/2018
• Supplement Dates Manufacturer Received: 07/17/2018
• Supplement Dates FDA Received: 08/03/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/28/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1