MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING SCREW 48MM- FOR IM NAILS; SCREW, FIXATION, BONE

Model Number	458.948
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arthritis (1723); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.A device history record (dhr) review was conducted: part # 458.948, synthes lot # h468496, supplier lot # n/a, release to warehouse date: 5/11/17, manufactured by: (b)(4), 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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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) 2022, the surgeon removed a tfna nail to convert the patient to a total hip.Patient was in pain and has arthritis of her hip.All tfna implants were removed successfully.Procedure was successfully completed.This report is for one (1) 5.0mm ti locking screw 48mm- for im nails.This is report 3 of 4 for complaint (b)(4).

• Brand Name: 5.0MM TI LOCKING SCREW 48MM- FOR IM NAILS
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13620535
• Report Number: 2939274-2022-00687
• Device Sequence Number: 5817850
• Product Code: HWC
• UDI-Device Identifier: 10886982230935
• UDI-Public: (01)10886982230935
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K000089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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 Expiration Date: 09/30/2026
• Device Model Number: 458.948
• Device Catalogue Number: 458.948
• Device Lot Number: H468496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 02/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2017
• 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: 12/125 DEG TI CANN TFNA 400/RIGHT - SILE; 5.0 TI LOCKING SCREW 80- FOR IM NAILS; TFNA SCREW 85MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female