MAUDE Adverse Event Report: RELIGN CORPORATION SHAVER HANDPIECE ATCLV; ARTHROSCOPE

Model Number	N/A
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined the unit was confirmed to be unable to produce rf plasma in stationary or oscillating mode.The pcba and surrounding rtv was found to be burnt and debris was present on the pcba and top cap surfaces.The distal rf contact was found to be damaged.There was no evidence of fluid ingress on the pcba and cavity within the top cap assembly.The surface on the electrode ring also showed evidence of burning.The rf function was found to be due to the electrical burnt pcba however the root cause cannot be determined due to the extent of the damage.; however, the repair was not completed because the unit was scrapped due to the extent of the damage.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The event is confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that the rf function stopped working in this handpiece during the middle of the surgery and the doctor was not able to use ablation or coagulation.No harm or delay reported.Evaluation of the device later found that the pcba and surrounding rtv was found to be burnt and the surface on the electrode ring also showed evidence of burning.No adverse events were reported as a result of this malfunction.

• Brand Name: SHAVER HANDPIECE ATCLV
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): RELIGN CORPORATION; 655 campbell technology pkwy; suite 275; campbell CA 95008
• Manufacturer (Section G): RELIGN CORPORATION; 655 campbell technology pkwy; suite 275; campbell CA 95008
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14357068
• Report Number: 3012790575-2022-00001
• Device Sequence Number: 4142872
• Product Code: HRX
• UDI-Device Identifier: 00859273007236
• UDI-Public: (01)00859273007236(11)210712
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K162770
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/10/2022

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: R10023
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown