MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 36MM-STERILE; APPLIANCE,FIXATION,NAIL

Model Number	412.212S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Necrosis (1971); No Code Available (3191)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier: (b)(6).Only event year is known.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(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 a removal of the femoral neck system (fns) due to avascular necrosis (avn).Initially, the patient had fns implantation on (b)(6) 2020.The procedure was successfully completed with a 30 minute surgical delay.There was no patient consequence reported.This product complaint, (b)(4), is related to (b)(4).(b)(4) captures the post-op event where the patient underwent a removal of the femoral neck system (fns) due to avascular necrosis (avn), while (b)(4) will capture the intra-op event where the surgeon experienced difficulty in the removal of the femoral neck system (fns) hardware due to the locking screw being cold welded to the plate, a removal tool was also bent during the removal process.Concomitant devices reported: femoral neck system plate 1 hole ¿ sterile (part number 04.168.000s, lot unknown, quantity 1), bolt for femoral neck system 95mm length-sterile (part number 04.168.295s, lot unknown, quantity 1), antirotation screw for femoral neck sys 95mm length ¿ sterile (part number 04.168.495s, lot unknown, quantity 1).This report involves 1 5.0mm ti locking scr slf-tpng w/t25 stardrive 36mm-sterile.This is report 4 of 4 for (b)(4).

• Brand Name: 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 36MM-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: 10206482
• Report Number: 2939274-2020-03024
• Device Sequence Number: 2134109
• Product Code: KTT
• UDI-Device Identifier: 10886982275394
• UDI-Public: (01)10886982275394
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K000682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/17/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 412.212S
• Device Catalogue Number: 412.212S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 06/29/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ANTIROTATION SCREW FOR FEMORAL NECK SYS 95MM; BOLT FOR FEMORAL NECK SYSTEM 95MM; FEMORAL NECK SYSTEM PLATE 1 HOLE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 100