MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RFNA / 12MM / 360MM 5 DEGREE BEND / STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 04.233.236S

Device Problem Migration (4003)

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Event Description

It was reported that on (b)(6), 2021 the patient underwent an initial surgery where an 85mm ans 5.0mm locking screw was inserted under power into the distal most screw hole of a 12mm x 360mm 5 degree bend retrograde femoral nail advanced in a lateral-to-medial fashion.Postoperatively on (b)(6) 2021 it was discovered that the screw described above had backed out laterally from the nail significantly.Revision surgery was required due to a non-union of the femur and was performed on (b)(6) 2022 when the screw was explanted and more blocking screws were inserted.The patient will continue to be followed by the surgeons clinic.Patient status is unknown.This report is for one (1) rfna / 12mm / 360mm 5 degree bend / sterile this is report 2 of 2 for complaint (b)(4).

Manufacturer Narrative

Additional patient identifier: (b)(6).Additional device product codes: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.Without a lot number the device history records review could not be completed.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 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: RFNA / 12MM / 360MM 5 DEGREE BEND / STERILE
• Type of Device: 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13502117
• MDR Text Key: 287352669
• Report Number: 2939274-2022-00406
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982290878
• UDI-Public: (01)10886982290878
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201346
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.233.236S
• Device Catalogue Number: 04.233.236S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: LOCKING SCREW FOR IM NAIL 5/ 86/ XL25
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 79 KG