MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.5MM TI RECON SCREW WITH T25 STARDRIVE 95MM-STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.003.029S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2021
Type of Reportable Event	Malfunction
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.Device history lot - a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 surgical procedure due to a gunshot wound with a non displaced basalar neck fracture.The patient had suffered a gunshot wound to the hip with a non displaced basalar neck fracture that extended into the trochanteric area.The surgeon had originally planned to go with a tfna, and elected to go with a femoral recon nail because of the patients' smaller stature and age.I advised that the frn was not indicated for trochanteric type fractures, but ultimately the surgeon elected to use the nail.During the case, the 3.2 guide pin for the recon screw missed the nail on initial entry; however it was determined that soft tissue was binding on the sleeve.The sleeves were readjusted, the guide pins and screws were inserted properly.Ultimately there were no allegations against the devices or adverse events.Procedure was completed successfully without any surgical delay.No patient consequence.Concomitant devcie reported: unk - guides/sleeves/aiming: aiming arm (part# unknown; lot# unknown; quantity: 1.This report is for one (1) 6.5mm ti recon screw with t25 stardrive 95mm-sterile.This is report 2 of 5 for complaint (b)(4).

• Brand Name: 6.5MM TI RECON SCREW WITH T25 STARDRIVE 95MM-STERILE
• 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: 12318344
• Report Number: 2939274-2021-04636
• Device Sequence Number: 4301170
• Product Code: HSB
• UDI-Device Identifier: 10886982081629
• UDI-Public: (01)10886982081629
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K040336
• 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): 07/15/2021

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: 04.003.029S
• Device Catalogue Number: 04.003.029S
• Device Lot Number: L490510
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 08/13/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3.2MM GUIDE WIRE 400MM; 6.5 TI RECON SCREW T25 SD 85-STERILE; 6.5 TI RECON SCREW T25 SD 95-STERILE; 8.5MM/3.2MM WIRE GUIDE FOR RECON LOCKING; 9 / TI CANN FRN / GT 340 / LEFT - SILE; UNK - GUIDE/COMPRESSION/K-WIRES; UNK - GUIDES/SLEEVES/AIMING: SLEEVE
• Patient Age: 65 YR
• Patient Weight: 54