MAUDE Adverse Event Report: STRYKER SPINE-FRANCE TECHTONIX INITIAL SCREWDRIVER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Model Number	48209030
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/02/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; connector driver broke at distal end of shaft when engaged into the axial rod to rod connector.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment.Results: the screwdriver was inspected and it was found that the tip was fractured.No relevant manufacturing issues were identified as all units met stryker specifications.The device was manufactured in 2005, making it over 11 years old at the time of the event.Conclusion: the most likely root cause is wear due to the device's extended use.
Event or Problem Description
It was reported that; connector driver broke at distal end of shaft when engaged into the axial rod to rod connector.

• Brand Name: TECHTONIX INITIAL SCREWDRIVER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6443537
• Report Number: 0009617544-2017-00117
• Device Sequence Number: 19051076
• Product Code: LXH
• UDI-Device Identifier: 07613327264852
• UDI-Public: (01)07613327264852
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2017

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: No Information
• Device Model Number: 48209030
• Device Catalogue Number: 48209030
• Device Lot Number: 051221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2017
• Initial Date Received by Manufacturer: 03/02/2017
• Supplement Date Received by Manufacturer: 03/02/2017
• Initial Report FDA Received Date: 03/29/2017
• Supplement Report FDA Received Date: 07/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 15 YR