MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., AGG. PLUS SHAVER BLADE, F - SERIES - 5.0MM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	0375757000
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/15/2019
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 distal tip of the device broke off.The broken piece was retrieved and the procedure was completed successfully.
Event or Problem Description
It was reported that the distal tip of the device broke off.The broken piece was retrieved and the procedure was completed successfully.
Additional Manufacturer Narrative
*updated part number from 375554000 to 375757000*.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Alleged failure: shaver blade got stuck in the patient and broke off the failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be blade comes in contact with a hard object causing damage to the teeth and hitting the housing edges.Excessive pressure, such as bending or prying, may cause the arthroscopic shaver blades to bend/break.

• Brand Name: PKG., AGG. PLUS SHAVER BLADE, F - SERIES - 5.0MM
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8331726
• Report Number: 0002936485-2019-00059
• Device Sequence Number: 11167783
• Product Code: GFA
• UDI-Device Identifier: 37613327061889
• UDI-Public: 37613327061889
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2019

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 Model Number: 0375757000
• Device Catalogue Number: 0375554000
• Device Lot Number: 16319CE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Initial Date Received by Manufacturer: 01/15/2019
• Supplement Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 02/12/2019
• Supplement Report FDA Received Date: 08/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1