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

Model Number	234-020-044
Medical Device Problem Codes	Overheating of Device (1437); Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/20/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that there was a potential of the device overheating.
Event or Problem Description
It was reported that there was a potential of the device overheating.
Additional 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
• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9461178
• Report Number: 0002936485-2019-00546
• Device Sequence Number: 379793
• Product Code: NBH
• UDI-Device Identifier: 07613154174812
• UDI-Public: 07613154174812
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 03/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1