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	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight unknown.Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 during a revision surgery that the removal of s1 screws that two implant holders broke.Additionally, while replacing the right s1 screw, two universal spine system-variable angle screws (uss-vas) broke - (the locking ring on the screw became dislodged and would not work).A third implant holder broke during final tightening, and a tip of the holder broke off into the left s1 screw and was not retrievable.It remained in the patient.While inspecting the uss-vas screwdrivers, it was discovered that the tips of the drivers were twisted.Replacements were requested.The revision surgery was captured as a postoperative event on a related product complaint (b)(4).Concomitant devices reported: unknown uss screws (part unknown, lot unknown, quantity 3).This is report 7 of 7 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Lot number dhr review was completed.Part no.: 314.132 , lot no.: l671242 , manufacturing location: haegendorf , release to warehouse date: 01.Dec.2017.No 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.Customer quality conducted an investigation of the returned device.It was reported that a 3.0mm hexagonal driver was found to be twisted.The 3.0mm hexagonal driver (314.132) is a component of the uss variable axis screw (vas) system for posterior fixation of the lumbar spine.The device is utilized for screw insertion.The returned instrument was examined and the complaint condition was able to be confirmed as the distal drive tip was found to be twisted.The failure mode of a twisted tip is likely the result of the application of excessive torque leading to deformation; hard patient bone or inadequate pedicle preparation may have contributed to the complaint conditions.The complaint condition cannot be replicated due to post-manufacturing damage.Relevant drawings for the returned device were reviewed (both current revision and from the time of manufacture): top-level.The design, materials and finishing processes were found to be appropriate for the intended use of this device.No dimensional analysis is possible due to post-manufacturing damage.A device history review, including material and hardness reviews, was performed for the returned instrument¿s lot number and no mrrs, ncrs or complaint-related issues were identified with the lot number which 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: 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: 7429933
• Report Number: 2939274-2018-51672
• Device Sequence Number: 11204846
• Product Code: HXX
• UDI-Device Identifier: 10705034769004
• UDI-Public: (01)10705034769004
• 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): 03/20/2018

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: 314.132
• Device Lot Number: L671242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2018
• Initial Date Received by Manufacturer: 03/20/2018
• Supplement Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 04/13/2018
• Supplement Report FDA Received Date: 05/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR