MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA HELICAL BLADE 105MM STERILE; SPIRAL BLADE

Model Number	04.038.305S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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 review: review of the device history record(s) on product code 04.038.305s with lot number h738487 showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.
Event or Problem Description
This is 2 of 2 for (b)(4).It was reported by the sales rep that on unknown date, the patient presented with 235mm tfna and non union after 5 months of surgery for an intertroch fracture.There was also a lateral femoral wall fracture below the blade hole.The nail broke at the proximal hole.The nail and blade were removed and revised to a long tfna and lag screw.The status of the patient post hardware removal was unknown.No additional information was provided.This report is for one (1) tfna helical blade 105mm sterile device.This complaint involves two (2) devices.

• Brand Name: TFNA HELICAL BLADE 105MM STERILE
• Common Device Name: SPIRAL BLADE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14250449
• Report Number: 2939274-2022-01536
• Device Sequence Number: 4398468
• Product Code: HSB
• UDI-Device Identifier: 10886982099051
• UDI-Public: 10886982099051
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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: 04.038.305S
• Device Catalogue Number: 04.038.305S
• Device Lot Number: H738487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Weight: 81 KG