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 Problem Break (1069)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/25/2020

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

Event Description

It was reported that the tip of the cutter broke during the procedure.The piece was retrieved.

Manufacturer Narrative

Alleged failure: the head of the cutter was broken during procedure.The failure(s) identified in the investigation is consistent with the complaint record.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 product was returned for investigation and the failure mode will be monitored for future reoccurrence.

Event Description

It was reported that the tip of the cutter 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: 10329695
• MDR Text Key: 201572606
• Report Number: 0002936485-2020-00303
• 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: 09/14/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 0375544000
• Device Lot Number: 19149CE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Initial Date Manufacturer Received: 07/02/2020
• Initial Date FDA Received: 07/27/2020
• Supplement Dates Manufacturer Received: 07/02/2020
• Supplement Dates FDA Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 28 YR