MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 40MM-STERILE; APPLIANCE,FIXATION,NAIL

Model Number	412.214S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reporter is company representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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 on (b)(6) 2020, the patient underwent an orthopedic procedure.The surgeon was removing the femoral neck system 1-hole plate because the surgeon was converting the femoral neck system 1-hole plate to a hemiarthroplasty.The femoral head had collapsed, and the bolt and the anti-rotational screw were no longer engaged in the femoral head.While attempting to remove the titanium locking screw through the femoral neck system 1-hole plate, it was discovered that the titanium locking screw was cold-welded into the femoral neck system 1-hole plate.The screw head became stripped due to multiple attempts to remove it with the screwdriver.The surgeon had to use a burr to weaken the screw and use bolt cutters to cut the screw from the plate.The surgeon was able to finally remove everything with extra effort.The procedure was successfully completed with a thirty-minute (30) of surgical delay.The patient's status is unknown.Concomitant device reported: unknown screwdriver (part # unknown, lot # unknown, quantity # 1); unknown fns anti-rotation (part # unknown, lot # unknown, quantity# 1); unknown fns bolt (part # unknown, lot # unknown, quantity # 1).This complaint involves two (2) devices.This is report 1 of 2 for (b)(4).

• Brand Name: 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 40MM-STERILE
• 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: 10105916
• Report Number: 2939274-2020-02621
• Device Sequence Number: 16898383
• Product Code: KTT
• UDI-Device Identifier: 10886982275417
• UDI-Public: (01)10886982275417
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K000682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/19/2020

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: 412.214S
• Device Catalogue Number: 412.214S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 06/01/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PL 1-HO F/FEM NECK SYST TAN; UNK - NAIL HEAD ELEMENTS: FNS ANTIROTATION; UNK - NAIL HEAD ELEMENTS: FNS BOLT; UNK - SCREWDRIVERS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 68