MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., DUAL EDGE SHAVER BLADE - 3.5MM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number 0475331000

Device Problems Break (1069); Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/27/2018

Event Type  malfunction  

Manufacturer Narrative

The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.

Event Description

It was reported that the distal tip bent/broke during use.It was also confirmed that all pieces were retrieved and the procedure was completed successfully.

Manufacturer Narrative

The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: the customer reported that while using during resection in a knee scope and distal tip bent/broke the failure identified in the investigation is consistent with the complaint record.The probable root cause/s could be bending/prying or came in contact with a hard object.The device manufacture date is not known.

Event Description

It was reported that the distal tip bent/broke during use.It was also confirmed that all pieces were retrieved and the procedure was completed successfully.

• Brand Name: PKG., DUAL EDGE SHAVER BLADE - 3.5MM
• 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: 8306781
• MDR Text Key: 135151691
• Report Number: 0002936485-2019-00050
• Device Sequence Number: 1
• Product Code: GFA
• 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: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0475331000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Date Manufacturer Received: 01/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1