MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/360MM-STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.013.552S
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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 that the patient sustained a second injury requiring a hemiarthroplasty.Originally, the patient was implanted with a retrograde nail.The nail was removed and replaced with a curved condylar plate that would allow for the hip implant stem to fit into the canal.The nail did not fail nor did it cause the second injury, it was only removed and replaced with a plate to fix his second injury.The procedure and the patient's status are unknown.This report is for one 11mm ti cann retro/antegrade femoral nail-ex/ 360mm-sterile.This is report 1 of 3 for (b)(4).

• Brand Name: 11MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/360MM-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: 9830847
• Report Number: 2939274-2020-01265
• Device Sequence Number: 726836
• Product Code: HSB
• UDI-Device Identifier: 10886982088048
• UDI-Public: (01)10886982088048
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K033618
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/17/2020

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: 04.013.552S
• Device Catalogue Number: 04.013.552S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 03/13/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR