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

Catalog Number 00882100600

Device Problems Break (1069); Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been returned for evaluation and investigation is in process.Once the investigation is complete, a supplemental report will be filed accordingly.

Event Description

It was reported that the light/power switch of the device was broken and does not stay on.Event timing was prior to surgery, during set up.No harm and no delay reported.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.The device history record for zimmer electric dermatome serial number (b)(4) was reviewed and noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The record review found no issues with the device and all verifications, inspections, and tests were successfully completed.Using the machine-repair reports and the repair sites folders on livelink as well as sap to query for all repairs on serial number (b)(4) prior to 13 february 2019, the device was noted to have not been previously repaired.The reported event was confirmed by the service technician who performed the evaluation and repair.On 13 february 2019, it was reported from tampa general hospital that a power supply had a broken light/power switch and would not stay on.The customer returned a zimmer electric dermatome power supply, serial number (b)(4), for evaluation.Evaluation of the device on 22 february 2019 confirmed that the power switch was broken.Repair of the power supply occurred the same day and involved replacing the switch on the device.The technician then verified that the device was functioning as intended and then returned the power supply to the customer without further incident.The device was tested, inspected, and repaired.Reference number (b)(4) on 13 february 2019.While the service technician confirmed the reported event and noted that the device was functioning as intended after the power switch was replaced, it cannot be determined from the information provided as to what lead to the power switch failing such that the power supply would not stay on.Therefore, a specific root cause of the reported event cannot be determined.

Event Description

No additional event information available.

• Brand Name: POWER SUPPLY, ELEC. DERMATOME
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8401651
• MDR Text Key: 138415127
• Report Number: 0001526350-2019-00155
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00882100600
• Device Lot Number: 63592328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1