MAUDE Adverse Event Report: SYNTHES MONUMENT T25 STARDRIVE SHAFT F/MATRIXCANNULATED/LONG; SCREWDRIVERS

Catalog Number	03.632.073
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Patient information not available for reporting.Device is an instrument and is not implanted/explanted.(b)(6).Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.No non-conformance reports were generated during production.Part number: 03.632.073, synthes lot number: 6773288: release to warehouse date: february 2, 2012.Mfg.Site: (b)(4).No non-conformance reports were generated during production.A product investigation was performed.It was reported that a t25 stardrive shaft for matrix cannulated ¿ long (03.632.073 lot 6773288 mfg.Feb-2012) stripped while adjusting the position of a screw.The procedure was able to be completed successfully with the complaint device; no surgical delay or patient harm reported.The returned stardrive shaft was examined and it was determined that each lobe of the drive tip was broken and missing a fragment.No definitive root cause was able to be determined however the failure mode is typically associated with attempted use when the driver is not fully seated in the screw¿s drive recess and/or the application of excessive force.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.No product design issues or discrepancies were observed.This complaint is confirmed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
(b)(6) reported that during a lumbar matrix mis (minimally invasive spine) fusion on (b)(6) 2016, the screwdriver stripped at the distal tip while adjusting the position of one of the screws.The surgeon corrected the position of the screw using the same screwdriver.The surgery was completed successfully.There was no surgical delay, and no reported harm to the patient.Concomitant device reported: unknown matrix screw (qty.1).

• Brand Name: T25 STARDRIVE SHAFT F/MATRIXCANNULATED/LONG
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6249044
• Report Number: 1719045-2017-10019
• Device Sequence Number: 359093
• Product Code: HXX
• UDI-Device Identifier: 10705034719177
• UDI-Public: (01)10705034719177(10)6773288
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2016

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 Catalogue Number: 03.632.073
• Device Lot Number: 6773288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/13/2017
• Supplement Report FDA Received Date: 01/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN MATRIX SCREW (PART # UNKNOWN)