MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12/130 DEG TI CANN TFNA 420/LEFT-STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.037.263S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2022, the patient underwent hardware removal of tfna nail, lag screw and distal screws.Transitioned/revised patient to a total hip arthroplasty.Patient outcome is unknown.This report involves one (1) 12mm/130 deg ti cann tfna 420mm/left-sterile.This is report 1 of 4 for (b)(4).
Additional Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is not expected to be returned for manufacturer review/investigation.Part # 04.037.263s, synthes lot # h759247, supplier lot # n/a, release to warehouse date: (b)(6) 2018, manufactured by: synthes monument no 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.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.(b)(4).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: 12/130 DEG TI CANN TFNA 420/LEFT-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: 13515046
• Report Number: 2939274-2022-00425
• Device Sequence Number: 11858492
• Product Code: HSB
• UDI-Device Identifier: 10886982097439
• UDI-Public: (01)10886982097439
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• 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: 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: 04.037.263S
• Device Catalogue Number: 04.037.263S
• Device Lot Number: H759247
• 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: 10/24/2018
• 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: 5.0 TI LCKNG SCREW T25 SD 40 F/IM NAIL-S; 5.0 TI LCKNG SCREW T25 SD 40 F/IM NAIL-S; TFNA FENESTRATED SCREW 100MM - STERILE; UNK - END CAPS: TFNA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 89 YR
• Patient Sex: Male
• Patient Weight: 91 KG