MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.0MM HEXAGONAL SCREWDRIVER WITH T-HANDLE; SCREWDRIVERS

Catalog Number	314.132
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Patient¿s weight is unknown.Device is an instrument and is not implanted/explanted.The subject device has been received and the product evaluation is in progress.No conclusion can be drawn.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 the screwdriver tip broke off in the left l5 universal spine system (uss) variable axis screw iii (vas iii) during placement of the screw on (b)(6) 2017.The tip was lodged in the screw.There was a lot of torque on the driver when the tip broke.The screw was not seated fully.The surgeon elected to remove the screw.The tip of the screwdriver was removed with the screw.There was five (5) minute surgical delay to remove the screw and place a new one.He placed a short rod on this screw and tightened the nut and collar and rotated the screw out using the rod (helicopter out).The surgeon then placed a new uss vas iii screw in the left l5.The surgeon then successfully completed the stage 1 procedure.The patient had a previous posterior lumbar fusion with stryker xia hardware.The surgeon planned to do a 2-stage procedure.The 1st stage was planned to remove the competitive hardware and place screws from t10-s1, and the 2nd stage at a later date to perform a pedicle subtraction osteotomy and place the rods and iliac screws.Concomitant device reported: 7.0 mm ti uss variable axis screw 50 mm thread length (part # 499.355, lot # h335569, quantity 1).This report is for one (1) 3.0 mm hexagonal screwdriver with t-handle.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
A device history record (dhr) review was performed for part no.: 314.132, lot no.: l286746: manufacturing location: (b)(4), release to warehouse date: 22.Mar.2017: 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 the product that would contribute to this complaint condition.A product investigation was performed.The returned instrument (part 314.132, lot l286746, mfg 22.Mar.2017) was inspected at customer quality and the complaint was confirmed.The instrument was returned with a broken distal tip.The tip was not returned.Whether this complaint could be replicated is not applicable because the device was returned broken.A visual inspection, drawing and device history record review were performed as part of this investigation.Material and hardness testing is not applicable at this time as they were tested at the time of manufactured and confirmed to have no issues through the dhr review.Dimensional analysis was not performed as relevant features were not returned.Relevant drawings were reviewed and were determined to be suitable for the intended design, application and dimensional conformity when used as recommended.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition therefor no further corrective and preventive actions are 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: 3.0MM HEXAGONAL SCREWDRIVER WITH T-HANDLE
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7088795
• Report Number: 2939274-2017-50178
• Device Sequence Number: 19077144
• Product Code: HXX
• UDI-Device Identifier: 10705034769004
• UDI-Public: (01)10705034769004(10)L286746
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2017

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: 314.132
• Device Lot Number: L286746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2017
• Initial Date Received by Manufacturer: 11/08/2017
• Supplement Date Received by Manufacturer: 01/15/2018
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 01/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR