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

Catalog Number 00882100600

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded under zimmer biomet complaint number (b)(4).The device has been returned for evaluation and investigation is in process.Once the investigation is completed, a supplemental report will be filed accordingly.

Event Description

It was reported that the unit was loosing strength to cut through issue; the same amount of power that it starts cutting with gets less and less as it cut.During procedure the power got less and less so by the end of the cut it was barely working, like it is losing power.There was no harm, no delay reported during surgery.No additional graft was needed.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, as final report.Reported issue: it was reported that the unit was loosing strength to cut through tissue; the same amount of power that it starts cutting with gets less and less as it cut.During procedure the power got less and less so by the end of the cut it was barely working, like it is losing power.Dhr and repair history review: the device history record (dhr) review noted no related non-conformances, requests for deviation, change notices or any other issues with manufacturing or with the device.The dhr review also found that all verifications, inspections and tests were successfully completed.Zimmer biomet surgical has not previously repaired/evaluated electric dermatome serial number (b)(6) as documented in the repair reports in livelink.Zimmer biomet surgical has not previously repaired/evaluated electric dermatome power supply serial number (b)(6) as documented in the repair reports in livelink.Technical review and physical examination: on may 28, 2019, it was reported that the unit was losing strength to cut through issue; the same amount of power that it starts cutting with gets less and less as it cut.During procedure the power got less and less so by the end of the cut it was barely working, like it is losing power.The customer returned an electric dermatome device, serial number (b)(6), for evaluation.The customer also returned a power supply, serial number (b)(6), for evaluation.Product review of the electric dermatome on june 13, 2019 revealed that the device would not run.The calibration was out of specifications at the zero setting only and the control bar was in the correct position.Product review of the electric dermatome power supply on june 12, 2019 revealed that the device functioned as intended and passed all required testing.Repair of the electric dermatome was performed by zimmer biomet surgical on june 13, 2019 which included replacement of the seal and strain relief, o-ring, motor, switch, plug harness assembly, semicircle shaft bearings, vespel bearings, and bearings.Electric dermatome, serial number (b)(6), was then tested and functioned properly.It was repaired, inspected and tested.Notification number 300174589 dated 6/12/2019.Notification number 300173183 dated 5/29/2019.Probable cause/root cause: while the returned product investigation confirmed that the electric dermatome was not running, it cannot be determined from the information provided what actually caused the reported event.Therefore, based on the information provided, 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.Conclusion: review of the information provided during the investigation determined there is no further actions needed at this time.This complaint will be tracked and trended for any adverse trends that may warrant further action.

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: 8697213
• MDR Text Key: 148071276
• Report Number: 0001526350-2019-00478
• 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: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• 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: 63924182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1