MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., 4MM FEMORAL AIMER; ACCESSORIES, ARTHROSCOPIC

Model Number 234-020-044

Device Problems Overheating of Device (1437); Mechanical Jam (2983)

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

Event Date 11/20/2019

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 there was a potential of the device overheating.

Event Description

It was reported that there was a potential of the device overheating.

Manufacturer Narrative

Alleged failure: the 2 drill bit were returned because after the first use (ok-no problem) it rubs when passing (+overheating) through the guide and then it blocks.After confirmation with the brand manager, it is the right drill bit used with the right guide.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root causes could be: 1) excessive force applied on device, 2) rough handling during reprocessing, 3) improper reprocessing methods, 4) improper drying, or 5) improper storage conditions.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.

• Brand Name: PKG., 4MM FEMORAL AIMER
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9461178
• MDR Text Key: 176583739
• Report Number: 0002936485-2019-00546
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 07613154174812
• UDI-Public: 07613154174812
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/17/2020

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 Model Number: 234-020-044
• Device Catalogue Number: 234-020-044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Initial Date Manufacturer Received: 11/20/2019
• Initial Date FDA Received: 12/12/2019
• Supplement Dates Manufacturer Received: 11/20/2019
• Supplement Dates FDA Received: 03/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1