MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE TRINKLE DRIVER SHAFT, 23/28/35MM BIOSTEON ACL SCREW; SCREWDRIVER

Model Number	234-010-235
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2021
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 the device broke during the procedure.No pieces broke off in the joint.
Event or Problem Description
It was reported that the device broke during the procedure.No pieces broke off in the joint.
Additional Manufacturer Narrative
Alleged failure: at the time of fitting the screw, the key cited was damaged.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: 1) excessive or insufficient force used, 2) screw inserted at an angle, 3) incorrect size of screw for tunnel/graft, 4) tap not used before insertion, or 4) driver not fully inserted into screw.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.

• Brand Name: TRINKLE DRIVER SHAFT, 23/28/35MM BIOSTEON ACL SCREW
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 11784100
• Report Number: 0002936485-2021-00243
• Device Sequence Number: 1021436
• Product Code: HXX
• UDI-Device Identifier: 04546540754912
• UDI-Public: 04546540754912
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2021

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: 234-010-235
• Device Catalogue Number: 234-010-235
• Device Lot Number: 307004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 07/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1