MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., AGG. PLUS SHAVER BLADE, INJECTION F-SERIES - 3.5MM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	0375534000
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was returned for investigation and the reported failure mode was confirmed.Alleged failure: the tip of cutter was fall apart during operation the failure(s) identified in the investigation is consistent with the complaint record.Based on the evaluation of this case 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.The failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the device broke during procedure.Additional information confirmed all pieces were retrieved.
Event or Problem Description
It was reported that the device broke during procedure.Additional information confirmed all pieces were retrieved.
Additional Manufacturer Narrative
Alleged failure: the tip of cutter was fall apart during operation.The failure identified in the investigation is consistent with the complaint record.Based on the evaluation of this case 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.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.

• Brand Name: PKG., AGG. PLUS SHAVER BLADE, INJECTION F-SERIES - 3.5MM
• 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: 8240697
• Report Number: 0002936485-2019-00014
• Device Sequence Number: 13854853
• Product Code: GFA
• UDI-Device Identifier: 37613327061742
• UDI-Public: 37613327061742
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2019

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 Catalogue Number: 0375534000
• Device Lot Number: 18067CE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2018
• Initial Date Received by Manufacturer: 12/17/2018
• Supplement Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 03/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1