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	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.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 removal procedure due to avascular necrosis (avn) of the femoral head on (b)(6) 2020, 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.Initially, the patient had fns implantation on (b)(6) 2020.It was also mentioned that the removal tool was bent during the removal process.A broken screw removal was used to remove the screw from plate.The procedure was successfully completed with 30 minutes surgical delay.There was no patient consequence reported.Concomitant device reported: fns antirotation screw (part # 04.168.495s, lot # unknown, quantity 1), fns bolt (part # 04.168.295s, lot # unknown, quantity 1).This is report 2 of 2 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: 10208081
• Report Number: 2939274-2020-03027
• Device Sequence Number: 2134111
• Product Code: KTT
• UDI-Device Identifier: 10886982275394
• UDI-Public: (01)10886982275394
• Combination Product (Y/N): N
• 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
• 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?: No
• Is this a Product Problem Report?: Yes
• 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
• Patient Age: 60 YR
• Patient Weight: 100