MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TFNA 380MM/LEFT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.037.159S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/ investigation.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 an unknown, patient underwent removal of titanium cannulated proximal femoral nailing system (tfna) and placing a total hip for an unknown reason.It was unknown if the surgery completed successfully.Patient status was unknown.Concomitant devices reported: unknown helical blade (part # unknown, lot # unknown, quantity 1), unknown locking screw (part # unknown, lot # unknown, quantity unknown).This complaint involves one (1) device.This report is for (1) 11mm/130 deg ti cann tfna 380mm/left - sterile.This is report 1 of 1 for (b)(4).

• Brand Name: 11MM/130 DEG TI CANN TFNA 380MM/LEFT - STERILE
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10779803
• Report Number: 2939274-2020-04954
• Device Sequence Number: 17067399
• Product Code: HSB
• UDI-Device Identifier: 10886982096678
• UDI-Public: (01)10886982096678
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/08/2020

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: 04.037.159S
• Device Catalogue Number: 04.037.159S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 11/03/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR