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 04.003.027S

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/15/2021

Event Type  malfunction  

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 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 device 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 3 of 5 for complaint (b)(4).

• Brand Name: 6.5MM TI RECON SCREW WITH T25 STARDRIVE 95MM-STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12318343
• MDR Text Key: 266393288
• Report Number: 2939274-2021-04641
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982081582
• UDI-Public: (01)10886982081582
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.003.027S
• Device Catalogue Number: 04.003.027S
• Device Lot Number: L950701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 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