MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LOCKING SCREW FOR IM NAIL Ø 5MM/ 90MM/ XL25; SCREW, FIXATION, BONE

Model Number	04.045.090
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Unspecified Infection (1930); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	06/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional narrative: additional procodes: jds, hsb.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a synthes employee.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.
Event or Problem Description
It was reported that on (b)(6) 2022, a patient sustained an open distal femur fracture from a gunshot wound.The fracture was treated with a retrograde femoral nail and interlocking screws.On (b)(6) 2022, the patient presented to the emergency department with a suspected infection.X-ray images showed delayed union and the migration of one oblique distal interlocking screw.On (b)(6) 2022, patient was brought to the operating room for irrigation and debridement and removal of migrated screw.The screw low prof lckng scr 5.0 / l 64 / xl25 was removed and replaced with screw locking screw for im nail 5/ 90/ xl25.It is unknown if there was a surgical delay.Procedure and patient outcome were unknown.No further information is available.This report is for a locking screw for im nail ø 5mm/ 90mm/ xl25.This is report 6 of 7 for (b)(4).

• Brand Name: LOCKING SCREW FOR IM NAIL Ø 5MM/ 90MM/ XL25
• 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): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15089411
• Report Number: 2939274-2022-02900
• Device Sequence Number: 4035257
• Product Code: HWC
• UDI-Device Identifier: 10886982293404
• UDI-Public: (01)10886982293404
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K201336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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: 04.045.090
• Device Catalogue Number: 04.045.090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: LOCKING SCREW FOR IM NAIL 5/ 32/ XL25; LOCKING SCREW FOR IM NAIL 5/ 34/ XL25; LOW PROF LCKNG SCR 5.0 / L 48 / XL25; LOW PROF LCKNG SCR 5.0 / L 64 / XL25; LOW PROF LCKNG SCR 5.0 / L 64 / XL25; RFNA / 10 / 360 5 DEG BEND / STERILE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 64 KG