MAUDE Adverse Event Report: SYNTHES MONUMENT SPORT GRIP T25 STARDRIVE SHAFTF/MATRIX-STANDARD; SCREWDRIVERS

Catalog Number	03.632.005
Medical Device Problem Codes	Fitting Problem (2183); Dull, Blunt (2407)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is an instrument and is not implanted/explanted.A device history record (dhr) review was performed for part # 03.632.005, synthes lot #6847814: release to warehouse date: 09-apr-2012, expiration date: n/a, manufactured by synthes (b)(4): no non-conformance reports (ncrs) were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.A product development investigation was performed.The returned instrument was examined and the complaint condition was able to be confirmed as the driver tip was found to be worn.A visual inspection and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.This complaint is confirmed.The sport grip t25 stardrive (03.632.005) is utilized in the matrix posterior pedicle screw, hook and rod fixation system.The driver is specifically utilized for screw and locking cap insertion per relevant technique guide.The sport grip t25 stardrive (03.632.005) was returned with a complaint condition of ¿stripped¿.The returned instrument was examined and the complaint condition was able to be confirmed as the driver tip was found to be worn.Replication of the complaint condition is not applicable as the device is already worn.No definitive root cause was able to be determined; the failure mode is typically associated with rough handling and/or attempted screw insertion when the driver is not firmly seated in the screw¿s drive recess.Relevant drawings for the returned instrument were reviewed.Dimensional analysis at the of the distal tip is not applicable due to post-manufacturing damage.No definitive root cause was able to be determined; the failure mode is typically associated with rough handling and/or attempted screw insertion when the driver is not firmly seated in the screw¿s drive recess.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.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 a matrix straight screwdriver malfunctioned during a l5-s1 fusion on (b)(6) 2017.The surgeon had placed his rods and was ready to place the caps.When the technician loaded the locking caps on the matrix t25 straight screwdriver, they kept falling off.The screwdriver would not retain the caps.We placed it on the back table and used a backup screwdriver to complete the surgery.The procedure was completed successfully and without patient harm.During manufacturer¿s investigation of the returned device it was identified that the driver tip is worn.This condition was re-evaluated and determined to be reportable on (b)(6) 2017.Concomitant devices reported: matrix locking cap without saddle (part # 09.632.099, lot# unknown, quantity # 2).This report is for one (1) sport grip t25 stardrive shaftf/matrix-standard this is report 1 of 1 for complaint (b)(4).

• Brand Name: SPORT GRIP T25 STARDRIVE SHAFTF/MATRIX-STANDARD
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6931931
• Report Number: 1719045-2017-11041
• Device Sequence Number: 11123734
• Product Code: HXX
• UDI-Device Identifier: 10705034718705
• UDI-Public: (01)10705034718705(10)6847814
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/15/2017

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: 03.632.005
• Device Lot Number: 6847814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2017
• Initial Report FDA Received Date: 10/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1