MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., AGG. PLUS SHAVER BLADE, F- SERIES - 4.0MM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number 0375544000

Device Problems Break (1069); Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/12/2019

Event Type  malfunction  

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 Description

It was reported that the device broke during the procedure.The piece was retrieved.

Manufacturer Narrative

The product was returned for investigation and the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: the head of aggressive plus cutter was fracture, and drop in patient body.The probable root cause/s could be the 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 device manufacture date is not known.

Event Description

It was reported that the device broke during the procedure.The piece was retrieved.

• Brand Name: PKG., AGG. PLUS SHAVER BLADE, F- SERIES - 4.0MM
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9904429
• MDR Text Key: 187116870
• Report Number: 0002936485-2020-00154
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 37613327061780
• UDI-Public: 37613327061780
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0375544000
• Device Lot Number: 18348CE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2020
• Date Manufacturer Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1