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

Catalog Number 00882100600

Device Problem Loss of Power (1475)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Customer has indicated that the product is in process of being 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 during biomedical testing, the unit motor output was weak/stops intermittently.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

(b)(4).On 11 march 2019, it was reported from st.Vincent's private werribee that the motor on a dermatome was weak and stopped intermittently.The customer had returned a zimmer electric dermatome power supply serial number (b)(4) as well as a zimmer electric dermatome for evaluation.Evaluation of the power supply on (b)(6) 2019 by zimmer australia noted that when another electric dermatome was attached to the device, the dermatome ran very slow and weak.The power supply was sent to dover for further evaluation and repair and the dermatome was returned to the customer.Evaluation of the device on (b)(6) 2019 found that the power supply did not provide a stable dc voltage.Repair of the device occurred the same day and involved replacing the internal power supply within the power supply.The technician then tested and verified that the device was functioning as intended and the power supply was returned to the customer without further incident.The device was tested, inspected, and repaired.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.While the service technician found that the power supply was not providing a steady dc voltage and that the power supply functioned as intended after the power supply within it was replaced, it cannot be determined from the information provided as to what caused the internal power supply to malfunction.Therefore, a specific root cause of the reported event 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 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: 8453617
• MDR Text Key: 139979159
• Report Number: 0001526350-2019-00193
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 05/06/2019

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 Catalogue Number: 00882100600
• Device Lot Number: 63669499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/11/2019
• Initial Date FDA Received: 03/26/2019
• Supplement Dates Manufacturer Received: 05/03/2019
• Supplement Dates FDA Received: 05/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1