MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 13MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/360MM-STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.013.752S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.Part 04.013.752s, lot 64p8672: manufacturing location: monument.Manufacturing date: august 06, 2020.Expiration date: june 30, 2029.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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 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 procedure.The surgeon decided to use a retro/antegrade femoral nail (rafn) for a proximal third femur fracture.While inserting the nail, the surgeon noticed a more proximal fracture extending around the lesser trochanter region.It¿s unclear if this fracture existed before the surgery.The surgeon ultimately decided to drive the nail in further proximal and used the lateral to medial locking screw options proximally along with one a top screw.The procedure was successfully completed without surgical delay.No patient consequences noted.This report is for a rafn.This is report 1 of 1 for (b)(4).

• Brand Name: 13MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/360MM-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
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13119488
• Report Number: 2939274-2021-07284
• Device Sequence Number: 17298190
• Product Code: HSB
• UDI-Device Identifier: 10886982088383
• UDI-Public: (01)10886982088383
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K033618
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: 04.013.752S
• Device Catalogue Number: 04.013.752S
• Device Lot Number: 64P8672
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 12/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Weight: 83 KG