MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE ANGLED AGG. PLUS SHAVER BLADE F-SERIES 4.0MM EACH - ORDER MULTIPLES OF 5; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	0380544100
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
Event or Problem Description
It was reported that the inner cylinder of the shaver was broken.During the elbow arthroscopy, it was apparently broken while shaving the area behind the portal insertion site.The doctor said that he may have used too much force, but he had used it many times before and had never had anything like this happen, so he asked him to have it checked.Customer replaced the device to complete the surgery.Per images received, the tip broke off close to the distal end but appears to have stayed inside the outer blade.
Event or Problem Description
It was reported that the inner cylinder of the shaver was broken.During the elbow arthroscopy, it was apparently broken while shaving the area behind the portal insertion site.The doctor said that he may have used too much force, but he had used it many times before and had never had anything like this happen, so he asked him to have it checked.Customer replaced the device to complete the surgery.Per images received, the tip broke off close to the distal end but appears to have stayed inside the outer blade.
Additional Manufacturer Narrative
Alleged failure: the inner cylinder of the shaver was broken.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause of the damage could be attributed to the blade coming into contact with a hard object, resulting in damage to the teeth and contact with the housing edges.Other potential factors include unintended excessive force applied by the user, such as bending or prying, which may cause the arthroscopic shaver blades to bend or break.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• Brand Name: ANGLED AGG. PLUS SHAVER BLADE F-SERIES 4.0MM 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: 21886775
• Report Number: 0002936485-2025-00372
• Device Sequence Number: 8189944
• Product Code: GFA
• UDI-Device Identifier: 37613327054997
• UDI-Public: 37613327054997
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2025

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: 0380544100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown