MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC T25 STARDRIVE SHAFT F/MATRIX CANNULATED/STANDARD; SCREWDRIVERS

Catalog Number	03.632.003
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is not available for reporting.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter is synthes sales consultant.A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn, as no product was received.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
Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that during a minimally invasive spine (mis) fustion procedure on (b)(6) 2018 utilizing matrix mis system, the surgeon noticed that the screws were poorly inserting into the pedicle.Once the case was completed, the scrub nurse noticed that both standard and long cannulated screwdriver shafts were slightly stripped and twisted at the distal end tip.There was no delayed obtained during surgery.The surgery was completed with no delay.Patient was not affected by this damage.Concomitant device reported: locking/set screws: matrix (part number unknown, lot number unknown, quantity 1).This report is for one (1) standard cannulated stardrive shaft for matrix.This is report 2 of 2 for (b)(4).
Additional Manufacturer Narrative
A review of the device history records has been requested.The device was received, the investigation is in progess, no conclusion could be drawn at the time of filing this report.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 history records review was completed for part# 03.632.003, lot# 6698504.Manufacturing location: (b)(4), release to warehouse date: dec 21, 2011.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product investigation was completed.Visual inspection observed the distal tip was slightly twisted.No new issues were identified.The given complaint condition agrees with the returned device condition and therefore the complaint was confirmed.Dimensional inspection: diameter of proximal to distal tip: 4.6 +0.03/- 0 mm.Measured dimensions: distal tip: 4.62 mm; conforming, device used: calipers ca215p.A review of the current design drawing and the drawing revision at the time of manufacture was performed and no issues were identified.A definitive root cause could not be determined based on the provided information.However, the failure mode is typically associated with the application of excessive force in the direction of screw insertion.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: T25 STARDRIVE SHAFT F/MATRIX CANNULATED/STANDARD
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7862899
• Report Number: 2939274-2018-53692
• Device Sequence Number: 19324515
• Product Code: HXX
• UDI-Device Identifier: 10705034718682
• UDI-Public: (01)10705034718682
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/22/2018

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: 03.632.003
• Device Lot Number: 6698504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Initial Date Received by Manufacturer: 08/22/2018
• Supplement Date Received by Manufacturer: 09/20/2018; 10/12/2018
• Initial Report FDA Received Date: 09/10/2018
• Supplement Report FDA Received Date: 10/09/2018; 10/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1