MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., 23MM BIOSTEON SCREW DRIVER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	234-020-234
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/14/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported the screw driver broke inside patient.
Additional Manufacturer Narrative
Alleged failure: biosteon screw driver broke off inside the biosteon screw and was wedged inside so we could not get the broken piece out of the screw.So the screw and broken up from the screw driver are inside the patients femoral tunnel.The metal tip is not a loose body inside the joint so the surgeon was not that worried about that.It was lodged in the screw so tightly that it should not be an issue.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: excessive force applied on driver, screw inserted at an angle, incorrect size of screw for tunnel/graft, tap not used before insertion, or driver not fully inserted into screw.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.The device manufacturer date is not known.
Event or Problem Description
It was reported the screw driver broke inside patient.

• Brand Name: PKG., 23MM BIOSTEON SCREW DRIVER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 7555472
• Report Number: 0002936485-2018-00468
• Device Sequence Number: 16597701
• Product Code: HXX
• UDI-Device Identifier: 07613154111190
• UDI-Public: 07613154111190
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 234-020-234
• Device Lot Number: 100683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Initial Date Received by Manufacturer: 05/14/2018
• Supplement Date Received by Manufacturer: 05/14/2018
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 09/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 18 YR