MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA HELICAL BLADE 100MM STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.038.300S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Impaired Healing (2378)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Investigation summary: 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 history: part number: (b)(4), lot number: 9909005, part manufacture date: 15-oct-2015 , manufacturing location: (b)(4), part expiration date: 30-sep-2025, nonconformance noted: n/a.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of tfna helical blade 100 mm product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Device was used for treatment, not diagnosis.
Event or Problem Description
It was reported that on (b)(6) 2020, the patient underwent removal of the trochanteric femoral nail advanced (tfna) system due to malreduction/ nonunion.The patient was originally implanted with the tfna system on an unknown date.This is report 1 of 4 for (b)(4).

• Brand Name: TFNA HELICAL BLADE 100MM STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10143093
• Report Number: 2939274-2020-02772
• Device Sequence Number: 19700156
• Product Code: HSB
• UDI-Device Identifier: 10886982099037
• UDI-Public: (01)10886982099037
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/01/2020

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 Expiration Date: 09/30/2025
• Device Model Number: 04.038.300S
• Device Catalogue Number: 04.038.300S
• Device Lot Number: 9909005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2020
• Initial Report FDA Received Date: 06/11/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 11 MM/130 DEG TI CANN TFNA 380 MM/LEFT - STERILE; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR