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	02/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is an instrument and is not implanted/explanted.A device history record review was performed on part # # 03.632.074, lot # 6670696: release to warehouse date: 20 may 2011, expiration date: na, manufactured by synthes (b)(4).No non conformance reports (ncr's) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A product development investigation was performed.The following parts were received with a complaint stating that instruments could not remove the locking leading to bending/breakage of the screwdrivers: t25 stardrive shaft with t-handle (03.632.074, lot 6670696, mfg 20-may-2011), t25 stardrive shaft ¿ standard (03.632.002, lot 6633364, mfg 08-aug-2011), straight tip t25 driver-standard (03.632.400, lot 7614367, mfg 14-oct-2011).The complaint against the returned instruments was confirmed.The tips of the 03.632.074 and 03.632.002 screwdrivers displayed spiral fractures.Five (5) tip fragments were returned that matched up to the broken screwdrivers and all exhibited torsional deformity with is consistent with the reported breakage during implant removal.Replication of the complaint is not applicable as the malfunctions were visually confirmed.The complaint description mentions that the surgeon attempted another technique specified in the technique guide after failing to remove the locking cap with the t-handle screw driver but the complaint description does not indicate that a torque limiting screwdriver handle was used with the screwdriver shafts.The matrix deformity and degenerative technique guides state to always use the torque limiting handle (03.620.061) to reduce risk of damage to the t25 screwdriver shaft.The technique addition also cautions to never use a fixed or ratcheting t-handle screwdriver to remove locking caps.If the torque limiting attachment is not used when using any of the stardrive shaft options, breakage of the driver may occur and could potentially harm the patient.A visual inspection, device history record (dhr) review, and drawing review were performed as part of this investigation.This complaint is confirmed.The t-handle t25 stardrive screwdrivers are one of ten t25 driver shafts intended to be utilized for screw insertion in the matrix system.Of the ten t25 drivers available in the system, only four are intended for final tightening with the use of a 10nm torque limiting ratchet handle and a countertorque.Relevant drawings were reviewed: the design, materials and finishing processes were found to be appropriate for the intended use of these devices.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 patient underwent a temporary implant of a synthes matrix hardware on an unspecified date in (b)(6) 2016.The patient was asymptomatic postoperatively.The surgeon planned the routine hardware removal on (b)(6) 2017.During the revision, upon trying to remove (one) 1 particular locking cap using a matrix locking cap driver, the cap would not turn and the t handle driver broke off into the locking cap.The surgeon removed the fragment with no problem, and attempted to unlock using the alternative removal technique listed in the technique guide.When using this technique, the surgeon used a different driver.It also broke off in the head of the cap.The surgeon removed the fragments with no problem.The surgeon then tried to loosen the cap using another star drive shaft.The shaft began to twist or bend but did not break.The surgeon then opted to use rod cutters to cut the rod contained within that screw and cap.He then removed a small rod segment, screw and cap all as one unit.Not being able to easily unscrew this locking cap added approximately 10 minutes to the case.No other ill effects to the patient, due to this delay, were reported.The patient status was not reported.Concomitant devices reported: rod cutter, rod segment, screw.This report is for one (1) t-handle t25 stardrive shaft f/matrix-long.This is report 2 of 4 for (b)(4).

• 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: 6368847
• Report Number: 1719045-2017-10161
• Device Sequence Number: 1031374
• Product Code: HXX
• UDI-Device Identifier: 10705034719184
• UDI-Public: (01)10705034719184(10)6670696
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/03/2017

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: 6670696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2017
• Initial Report FDA Received Date: 03/01/2017
• 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: ROD CUTTER (PART # UNKNOWN, QTY UNKNOWN); ROD SEGMENT (PART # UNKNOWN, QTY UNKNOWN); SCREW (PART # UNKNOWN, QTY UNKNOWN)
• Patient Age: 37 YR
• Patient Weight: 61