MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12 / TI CANN FRN / PF 380 / RIGHT - SILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.033.238S
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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.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 on (b)(6) 2021, patient underwent a revision using the depuy synthes femoral recon nail, piriformis entry procedure.Initially patient was operated on in (b)(6) fifteen years ago and was never healed.Patient had a midshaft femur fracture treated with a piriformis entry femoral nail of unknown manufacturer.The surgeon and his partner reamed up to 13.5mm and used a 12mm x 380mm right side nail.When the nurse opened the package, the surgeons commented on the curve of the nail being more of a sharp bend than a curve.During implanting the nail, the nail would not pass further than midshaft due to the extreme bend of the nail, as it was meeting resistance both proximally and at midshaft.The surgeons ended up having to over-ream by (1) - (2)mm both proximally and at the isthmus.Procedure was completed successfully with (20) minutes delay.We compared a tfna nail with the frn because they have the same radius of curvature, but the curve is drastically different in geometry.This report is for (1) 12 / ti cann frn / pf 380 / right - sile.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 12 / TI CANN FRN / PF 380 / RIGHT - SILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12538037
• Report Number: 2939274-2021-05783
• Device Sequence Number: 1271355
• Product Code: HSB
• UDI-Device Identifier: 10886982271419
• UDI-Public: (01)10886982271419
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K172157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/30/2021

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: 04.033.238S
• Device Catalogue Number: 04.033.238S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 09/27/2021
• Patient Sequence Number: 1
• Patient Weight: 72