MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11.0MM TI HELICAL BLADE 120MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	456.309
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(4) 2022, patient underwent a hardware removal and revision surgery.There was a fracture that occurred below the nail.Procedure outcome and patient status are unknown.This report is for a 11.0mm ti helical blade 120mm.This is report 2 of 3 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: additional procode: hwc complainant part is not expected to be returned for manufacturer review/investigation.Part: 456.309-us synthes lot: 11l9336 supplier lot: n/a release to warehouse date: july 01, 2019 manufactured by: synthes (b)(4).No nonconformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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.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.

• Brand Name: 11.0MM TI HELICAL BLADE 120MM
• 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): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13518369
• Report Number: 2939274-2022-00461
• Device Sequence Number: 14504792
• Product Code: HSB
• UDI-Device Identifier: 10886982226792
• UDI-Public: (01)10886982226792
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K011857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,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: 456.309
• Device Catalogue Number: 456.309
• Device Lot Number: 11L9336
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 12/130 DEG TI CANN TROCH FIXATION NL 170; 5.0 TI LOCKING SCREW 42- FOR IM NAILS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male