MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING SCR SLF-TPNG WITH T25 STARDRIVE RECESS 30MM; APPLIANCE,FIXATION,NAIL

Model Number	412.209
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Patient¿s weight is unknown.Implant date: unknown.(b)(6).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 during a revision surgery on (b)(6) 2017, to remove a synthes titanium distal femur less invasive stabilization system (liss) plate and thirteen (13) screws, three (3) synthes screwdrivers broke when the surgeon attempted to remove three (3) cold welded / cross threaded screws from the plate.One (1) liss plate along with approximately thirteen (13) unknown screws were initially implanted on an unknown date a few years ago.The patient had a fracture which was slightly distal to the synthes liss femur plate and the plan was to revise the patient to another zimmer plate.Hence the revision surgery was conducted.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 screws that were cold welded were the only ones that broke / got damaged to remove them during the 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 intraoperative issue of three (3) broken screwdrivers and three cold welded / cross threaded screws that were stuck to the plate.The postoperative revision due to patient¿s fracture which was slightly distal to the synthes liss femur plate has been captured under linked complaint (b)(4).Concomitant devices reported: screws (part # unknown, lot # unknown, quantity # 10), liss plate (part # 422.348, lot # 2142869, quantity # 1).This report is for one (1) 5.0 mm ti locking screw.This is report 4 of 6 for complaint (b)(4).
Additional Manufacturer Narrative
A device history record review was performed for the subject device: part no.: 412.209 , lot no.: 3217863 , manufacturing location: (b)(4), release to warehouse date: 27.Jul.2009.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.A product development investigation was performed for the subject device: the 5.0mm locking screw self-tapping, is available in the less invasive stabilization system (liss).The returned device was found to be seized within the concomitant liss plate (422.348 lot 2142869), as such the complaint condition was able to be replicated and confirmed.Additional examination found the drive recess to be stripped.Based on the complaint condition this likely occurred during attempted screw removal of the cold-welded screw.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 as the device is unable to be removed from the plate.A device history review, including material and hardness reviews, 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 30MM
• 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: 7120703
• Report Number: 2939274-2017-50288
• Device Sequence Number: 11077641
• Product Code: KTT
• UDI-Device Identifier: 10886982210937
• UDI-Public: (01)10886982210937(10)3217863
• 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 412.209
• Device Catalogue Number: 412.209
• Device Lot Number: 3217863
• 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
• Patient Age: 84 YR