MAUDE Adverse Event Report: 655 CAMPBELL TECHNOLOGY PKWY 3 IN 1 SHAVER 5.0MM; ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

Model Number	N/A
Medical Device Problem Codes	Flaked (1246); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation into the reported event has been initiated under (b)(4).Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.
Event or Problem Description
It was reported that during surgery the 5.0mm three in one relign shaver was making a grinding noise when in bone cutting mode.After they used it in the shoulder joint there was metal shavings in the patient.They changed out the disposable shaver and the noise continued.There was no patient injury.There was no medical/surgical intervention required to complete the surgery.There was no surgical delay or complication.The foreign body was not retained.The surgical technique for the product was utilized.When they switched out both the handpiece and the shaver that resolved the issue.Due diligence is complete, there is no additional information available.
Event or Problem Description
There is no additional information available.
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).The complaint was confirmed.Based on the investigation, the 3-in-1 shaver 5.0mm was observed with striations on the inner sheath tip, markings on the ceramic tip, and metal shavings on the coupler magnets.The metal shavings observed on the coupler magnets indicate any metal shavings that could have occurred were likely suctioned through the 3-in-1 shaver and to the coupler magnets where they remained for the investigation.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.

• Brand Name: 3 IN 1 SHAVER 5.0MM
• Common Device Name: ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
• Manufacturer (Section D): 655 CAMPBELL TECHNOLOGY PKWY; 655 campbell technology pkwy; campbell CA 95008
• 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: 18238921
• Report Number: 0001526350-2023-01567
• Device Sequence Number: 14253390
• Product Code: HRX
• UDI-Device Identifier: 00859273007144
• UDI-Public: (01)00859273007144(17)220616(10)F22F16-03
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2024

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 Expiration Date: 06/16/2024
• Device Model Number: N/A
• Device Catalogue Number: R10014
• Device Lot Number: F22F16-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2023
• 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: 11/07/2023
• Supplement Date Received by Manufacturer: 03/18/2024
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Concomitant Medical Products and Therapy/Usage Dates: R10023.SHAVER HANDPIECE.SN: (B)(6).
• Patient Age: 17 YR
• Patient Sex: Male