MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING SCR SLF-TPNG WITH T25 STARDRIVE RECESS 32MM; APPLIANCE,FIXATION,NAIL

Model Number	412.210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional patient¿s identifier: (b)(6).(b)(4).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 a patient underwent a revision of a titanium distal femur less invasive stabilization system (liss) plate and thirteen (13) screws to an unknown zimmer plate construct due to a fracture which was slightly distal to the synthes liss femur plate on (b)(6) 2017.One (1) liss plate along with approximately thirteen (13) unknown screws were initially implanted on an unknown date a few years ago.Based on a previously taken x-ray (unavailable) taken before the revision surgery, the plate and screws all seemed intact and were found intact during surgery.The revision procedure was successfully completed with an unknown delay in surgery due to three (3) synthes screwdrivers breaking while removing the three (3) cold welded / cross threaded screws that were stuck to the plate.After the screwdrivers broke, the screws had to be cut out with a big burr.It is unknown if there were any fragments left inside the patient.This report addresses the postoperative revision due to patient¿s fracture which was slightly distal to the synthes liss femur plate the intraoperative issue of cold welded / cross threaded screws that were stuck to the plate.The intraoperative issue of three (3) broken screwdrivers and three cold welded / cross threaded screws that were stuck to the plate has been captured under linked complaint (b)(4).This report is for one (1) 5.0mm ti locking screw self-tapping with t25 stardrive recess 32mm this is report 4 of 11 for complaint (b)(4).
Additional Manufacturer Narrative
A device history record (dhr) review was performed for part no.: 412.210, lot no.:1983415, manufacturing location: (b)(4), release to warehouse date: 15.Sep.2008: 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 5.0mm ti locking screw self tapping with t25 stardrive recess 32mm is available in the less invasive stabilization system (liss).The system allows percutaneous plate insertion and targeting of screws in the distal femur.The returned device was examined and no defects or deficiencies were identified which may have contributed to the complaint of periprosthetic fracture.Whether the complaint condition is able to be replicated is not applicable to this complaint condition.Relevant drawings for the returned device were reviewed (both current revision and from the time of manufacture).The design, materials and finishing processes were found to be appropriate for the intended use of this device.No dimensional analysis is applicable as there is no allegation against the device.A device history review, including material review, was performed for the returned device¿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.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: 5.0MM TI LOCKING SCR SLF-TPNG WITH T25 STARDRIVE RECESS 32MM
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7121192
• Report Number: 2939274-2017-50297
• Device Sequence Number: 1423539
• Product Code: KTT
• UDI-Device Identifier: 10886982210944
• UDI-Public: (01)10886982210944(10)1983415
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K000682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 412.210
• Device Catalogue Number: 412.210
• Device Lot Number: 1983415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2017
• Initial Date Received by Manufacturer: 11/15/2017
• Supplement Date Received by Manufacturer: 01/10/2018
• Initial Report FDA Received Date: 12/15/2017
• Supplement Report FDA Received Date: 01/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention