MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11/130 DEG TI CANN TFNA 400/RIGHT - SILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.037.160S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
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, the patient underwent removal surgery due to a broken trochanteric fixation nail advanced (tfna) nail.No further complication to the patient and the nail was implanted shortly after.The procedure outcome and patient's status are unknown.Concomitant device reported: unk - nail head elem: tfna helical blade (part#: unknown, lot#: unknown, quantity: 1).Unk - screws: locking: trauma (part#: unknown, lot#: unknown, quantity: unknown).This report is for (1) 11mm/130 deg ti cann tfna 400mm/right - sterile.This is report 1 of 1 for (b)(4).

• Brand Name: 11/130 DEG TI CANN TFNA 400/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: 12674177
• Report Number: 2939274-2021-06226
• Device Sequence Number: 1454866
• Product Code: HSB
• UDI-Device Identifier: 10886982096685
• UDI-Public: 10886982096685
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted 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): 09/24/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.037.160S
• Device Catalogue Number: 04.037.160S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 10/21/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention