MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE DUAL EDGE SHAVER BLADE 5.5MM EACH - ORDER MULTIPLES OF 5; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	0475361001
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the shaver blade broke off during surgery.The pieces potentially remained in the patient as it was not confirmed after multiple attempts.
Additional Manufacturer Narrative
Per additional information received, all broken pieces were retrieved.Based on this, this event is no longer determined to be a serious injury mdr and is now determined to be a malfunction mdr.
Event or Problem Description
It was reported that the shaver blade broke off during surgery.Per additional information received, all broken pieces were retrieved.
Additional Manufacturer Narrative
Alleged failure: shaver blade broke off during surgery.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause of the failure could be excessive force applied by the user, such as bending or prying, which may lead to the bending or breaking of the arthroscopic shaver blades.Additionally, the blade may have come into contact with a hard object, which could have damaged the teeth and impacted the housing edges.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the shaver blade broke off during surgery.Per additional information received, all broken pieces were retrieved.

• Brand Name: DUAL EDGE SHAVER BLADE 5.5MM EACH - ORDER MULTIPLES OF 5
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: lucas wolski ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 21820315
• Report Number: 0002936485-2025-00329
• Device Sequence Number: 18302810
• Product Code: GFA
• UDI-Device Identifier: 37613327512343
• UDI-Public: 37613327512343
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0475361001
• Device Lot Number: 24043CE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2025
• Supplement Date Received by Manufacturer: 04/17/2025; 06/26/2025
• Initial Report FDA Received Date: 04/10/2025
• Supplement Report FDA Received Date: 04/29/2025; 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White