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

Model Number N/A

Device Problem Loss of Power (1475)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).(b)(4).The investigation is still in progress.Once the investigation is complete a follow up mdr will be submitted.

Event Description

It was reported that unit's light/power switch was broken.It didn't stay on.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This follow up report is being submitted to report additional information.The following sections were updated: b4, b5, g4, h1, h2, h3 h6, h10.The device history record for zimmer electric dermatome power supply 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 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.Using view 09-23 from the etq reliance system, there were 7 complaints from (b)(6) 2018 to (b)(6) 2019 that contain the same part number as the device involved with the reported event that used the character string broke in the event.Using view 09-23 from the etq reliance system, there was 1 complaint from (b)(6) 2018 to (b)(6) 2019 that contain the same part number and manufacturing date as the device involved with the reported event that also used the character string broke in the event.Using view 09-23 from the etq reliance system, there was 1 complaint from (b)(6) 2018 to (b)(6) 2019 that contain the same part number as the device involved with the reported event, used 63592328 as the lot number for the device, and used the character string broke in the event.The reported event was confirmed by the service technician who performed the evaluation and repair.On 13 february 2019, it was reported from (b)(6) hospital that the power switch on a power supply was broken and wouldn't stay on.The customer returned a zimmer electric dermatome power supply, serial number (b)(4), for evaluation.Evaluation of the device on 26 february 2019 noted that the power switch was broken and that the power supply did not provide an output.Repair of the power supply occurred the same day and involved replacing the power switch and the internal power supply component on the device.The technician then tested and verified that the power supply was functioning as intended and returned it to the customer without further incident.The device was tested, inspected, and repaired.Reference number (b)(4) on (b)(6) 2019.While the service technician found that the power switch on the power supply was broken and found that the device was not providing an output voltage, it cannot be determined as to what caused the device to break down such that the power switch would break and the device would provide inadequate voltage.Therefore, based on the information provided, a specific root cause of the reported issue cannot be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

Event Description

No additional information.

• 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: 8413334
• MDR Text Key: 138561471
• Report Number: 0001526350-2019-00160
• 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: 03/18/2019

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: 63592328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/13/2019
• Initial Date FDA Received: 03/12/2019
• Supplement Dates Manufacturer Received: 03/18/2019
• Supplement Dates FDA Received: 03/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1