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

Model Number	234-020-044
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/20/2019
Type of Reportable Event	Malfunction
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(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: excessive force applied on device, rough handling during reprocessing, improper reprocessing methods, improper drying, or improper storage conditions.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.No manufacturing date - the device manufacturer date is not known.
Event or Problem Description
Per investigation results, it was reported that the guide was blocked, which could potentially lead to overheating.There is no alleged patient involvement.

• Brand Name: 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: 9835908
• Report Number: 0002936485-2020-00124
• Device Sequence Number: 14270856
• 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
• Report Date (Section B): 03/16/2020

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: 0234020044
• Device Lot Number: 623736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 03/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1