MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. 3 IN 1 SHAVER 4.2MM; ARTHROSCOPE

Model Number	N/A
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).Evaluation and investigation are in process.Once the investigation is complete, a supplemental report will be filed.
Event or Problem Description
It was reported that during surgery more metal flakes coming off the 4.2 relign 3-in-1 blades in oscillation mode.No harm or delay were reported.Due diligence information in process.No additional information available at this time.
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 4.2mm was observed with striations on the inner sheath tip which is evidence of metal particulate generation.The most likely root cause for the ¿metal flakes¿ is the failure of the concentricity of the inner sheath and the outer sheath.It is recommended to disposition the complaint 3-in-1 shaver 4.2mm as scrap.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 during surgery more metal flakes coming off the 4.2 relign 3-in-1 blades in oscillation mode.There was a patient involved but no intervention, delay, and no foreign body was retained.Due diligence information complete.No additional information is available.

• Brand Name: 3 IN 1 SHAVER 4.2MM
• Common Device Name: ARTHROSCOPE
• 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: 18783996
• Report Number: 0001526350-2024-00268
• Device Sequence Number: 7757509
• Product Code: HRX
• UDI-Device Identifier: 00859273007083
• UDI-Public: (01)00859273007083(11)231115(10)F23L15-01
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 06/27/2024

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: 11/15/2025
• Device Model Number: N/A
• Device Catalogue Number: R10008
• Device Lot Number: F23L15-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/31/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2023
• 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
• Patient Sex: Prefer Not To Disclose