MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. SHAVER HANDPIECE ATCLV; ARTHROSCOPIC SHAVER SYSTEM HANDPIECE, LINE-POWERED

Catalog Number	R10023
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event is recorded with zimmer biomet under (b)(4).This medwatch is being filed as an initial / final report based on information discovered during the device evaluation.The complaint was confirmed.Based on the investigation, the complainant describes two different issues related to rf functionality and the fit of the soaking cap.The complaint was confirmed, issues were observed with both rf functionality and the fit of the soaking cap.The lack of rf functionality was due to a wire that was not positioned correctly when the handpiece pcba was secured during manufacturing.The violet wire responsible for rf return was crimped and exposed, resulting in the wire shorting.The soaking cap was difficult to remove without the use of extreme force.The complaint soaking cap was functional with other raymo cables.The complaint raymo cable was observed difficult to connect and remove.It is recommended to disposition the complaint handpiece as scrap.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.For the soaking cap issue a definitive root cause cannot be determined.For the rf functionality issue the root cause of the reported issue is attributed to a manufacturing deficiency.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 before surgery when the device was plugged in to test it prior to patient use, the cautery was not working, not cutting.The sterilization cap can 't be removed without putting it in a vice.There was no patient involvement.During device evaluation, it was discovered that there were no metal wires exposed outside of the device upon arrival, the exposed wire was found after disassembly to further investigate the failure.Due diligence is complete, no further information is available.

• Brand Name: SHAVER HANDPIECE ATCLV
• Common Device Name: ARTHROSCOPIC SHAVER SYSTEM HANDPIECE, LINE-POWERED
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 20260146
• Report Number: 0001526350-2024-01105
• Device Sequence Number: 7563726
• Product Code: HRX
• UDI-Device Identifier: 00859273007236
• UDI-Public: (01)00859273007236(11)240222
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K233493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/19/2024

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 Catalogue Number: R10023
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose