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

Catalog Number	03.632.075
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight is not provided for reporting.Device is an instrument and is not implanted/explanted.Device history record (dhr) review was performed on the part# 03.632.075 lot# 7575340: release to warehouse date: 9-may-2014, supplier: (b)(4).No non conformance reports (ncrs) were generated during production.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.A product development investigation was performed.The returned screwdriver was found to have a worn tip.The device has surface wear which does not impact functionality.A visual inspection, drawing review and dhr review were performed as part of this investigation.The complaint is confirmed.Replication of the complaint condition is not applicable as the screwdriver tips are already worn.The t25 startdrive screwdrivers are noted in the matrix spine system - degenerative technique guide.The drawings were reviewed during investigation.The design history was not found to impact the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for the intended use when employed.No definitive root cause was able to be determined.The failures are likely related to cumulative wear on the devices over time.There were no issues during the manufacture of this product that would contribute to this 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 with degenerative disc disease underwent a posterior lateral fusion at l2-s1 on (b)(6) 2016.While the surgeon was engaging the locking cap into the screw head, the locking cap fell off of the stardrive shaft.The locking cap was picked up with forceps and placed back on the stardrive shaft and the surgeon was able to engage the locking cap with the screw head.The surgeon went on to place a second locking cap and experienced the same issue with the locking cap falling off the same stardrive shaft.The second locking cap was picked up with forceps and placed back on the stardrive shaft and the surgeon was able to engage the locking cap with the screw head.Another stardrive shaft was used and the third locking cap fell off.The surgeon picked up the locking cap with forceps and placed it back on the stardrive shaft and was able to engage the locking cap with the screw head.All three (3) locking caps were placed successfully.During final tightening of the last locking cap, the straight tip driver (torque shaft) broke in half.Approximately 10mm of the shaft broke off.The tip stayed in the locking cap when it broke.The broken tip was retrieved from the locking cap and another straight tip driver (torque shaft) was used to final tighten the locking cap.The same locking cap was used.There were no fragments generated.The broken tip was discarded.The torque limiting ratchet handle was used with the straight tip driver (torque shaft).There was no reported issue with the torque limiting ratchet handle.All locking caps were placed successfully and implanted in the patient.There was a two minute surgical delay.There was no additional medical intervention.Routine intraoperative o-arm scans were taken as standard for the procedure.The procedure was completed successfully.The patient was reported as stable.The stardrive shaft used for the first and second locking cap was the same stardrive shaft.A second stardrive shaft was used for the third locking cap.During the manufacturer investigation process it was identified that the returned screwdriver was found to have a worn tip.This condition was re-evaluated and determined to be reportable on january 26, 2017.Concomitant devices reported: matrix locking caps (part # 09.632.099, lot # unknown, quantity 3) and 10nm torque limiting ratchet handle (part # 03.620.061, lot # 6436702, quantity 1).This is report 2 of 3 for (b)(4).

• Brand Name: SPORT GRIP T25 STARDRIVE SHAFTF/MATRIX-LONG
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6307571
• Report Number: 1719045-2017-10088
• Device Sequence Number: 635060
• Product Code: HXX
• UDI-Device Identifier: 10705034719191
• UDI-Public: (01)10705034719191(10)7575340
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 12/14/2016

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: 03.632.075
• Device Lot Number: 7575340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2017
• Initial Report FDA Received Date: 02/07/2017
• 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: ONE (1) TORQUE LIMITING RATCHET HANDLE; THREE (3) MATRIX LOCKING CAPS
• Patient Age: 63 YR