MAUDE Adverse Event Report: SYNTHES MONUMENT T-HANDLE T25 STARDRIVE SHAFT F/MATRIX-LONG; SCREWDRIVERS

Catalog Number	03.632.074
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is an instrument and is not implanted/explanted.Part 03.632.074, synthes lot 6495490: release to warehouse date: may 17, 2011.Supplier: (b)(6).No non-conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacturing of this product that would contribute to this complaint condition.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.
Event or Problem Description
It was reported that during a revision surgery to expand a previously implanted matrix construct, the tip of a synthes screwdriver broke off while the surgeon was attempting to remove a matrix locking cap.The broken tip was retained in the locking cap but was removed easily and did not fall into the patient.The patient was initially implanted on an unknown date with matrix devices at the l4-s1 levels, and this revision was scheduled to extend the construct to include the t10 -s1 levels.The revision was scheduled because the patient is morbidly obese with severe stenosis after the surgeon was reviewing x-ray images during a routine follow-up appointment.The surgeon was able to complete the surgery with another screwdriver and no surgical delays or adverse events were reported.Concomitant device reported: ti matrix locking cap (part 04.632.000, lot unknown, quantity 1).This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
: following device was returned for cq investigation; scrdriver t25 long w/t-handle f/matrix p/n 03.632.074, lot# 6495490.Customer quality (cq) engineering investigation: this complaint condition is confirmed.The screwdriver tip (distal end) is broken and missing a fragment.The fragment was not returned with the complaint.The complaint condition cannot be replicated due to device being already broken.No new malfunctions were identified as a result of the investigation.T-handle t25 startdrive long shaft screw driver is an operation instrument for matrix spine system ¿ posterior pedicle screw and rod fixation system.A visual inspection under 5x magnification, dimensional inspection of feature(s) related to this complaint, device history record (dhr) review and drawing review were performed as part of this investigation.Visual inspection: the screwdriver tip (distal end) is broken and missing a fragment.The fragment was not returned with the complaint.The device shows some wear and scratches which does not impact device functionality.A fragment approx.1.6 to 1.9 mm is missing from the tip.Three measurements were taken of the shaft diameter that precedes the device tip.Three measurements were taken which averaged at 4.62mm which is within the specification 4.6 mm +0.03/-0.Dhr review for part: #03.632.074 synthes lot # 6495490.Release to warehouse date:17may11.Supplier: universal punch.No ncrs were generated during production.Review of the device history records showed that there were no issues during the manufacturing of this product that would contribute to this complaint condition.Drawing review: drawing (mfg and current) screwdriver shaft and (mfg and current) top level drawing were reviewed during this investigation.No product design issues or discrepancies were observed.Unable to determine an exact root cause.It is possible that rough handling during operation and/or sterilization process, application of excessive/off-axis force during operation may have caused the issue.Device age is 6 years and it can be inferred from the visual inspection that it had been used multiple times during its service period.Corrected data: 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.

• Brand Name: T-HANDLE T25 STARDRIVE SHAFT F/MATRIX-LONG
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6689141
• Report Number: 1719045-2017-10630
• Device Sequence Number: 19325553
• Product Code: HXX
• UDI-Device Identifier: 07611819377301
• UDI-Public: (01)07611819377301(10)6495490
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2017

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: Health Professional
• Device Catalogue Number: 03.632.074
• Device Lot Number: 6495490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2017
• Initial Date Received by Manufacturer: 06/07/2017
• Supplement Date Received by Manufacturer: 07/14/2017
• Initial Report FDA Received Date: 07/06/2017
• Supplement Report FDA Received Date: 07/17/2017
• 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: 1 PART 04.632.000, LOT UNKNOWN, LOCKING CAP