MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM CORTEX SCREW SELF-TAPPING 32MM; SCREW, FIXATION, BONE

Model Number	214.832
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	05/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Reporter is a j&j employee.Complainant part is not expected to be returned for manufacturer review/investigation.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 there was a removal of the variable angle (va) condyle plate and corresponding screws due to nonunion/malunion.The surgeon removed the plate and screws, realigned the femur, inserted im nail, and inserted bone graft obtained via radioimmunoassay (ria) procedure.There was no patient consequences.This report is for (1) 4.5mm cortex screw self-tapping 32mm.This is report 2 of 12 for complaint (b)(4).

• Brand Name: 4.5MM CORTEX SCREW SELF-TAPPING 32MM
• 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: 14654133
• Report Number: 2939274-2022-02205
• Device Sequence Number: 17373042
• Product Code: HWC
• UDI-Device Identifier: 10886982154651
• UDI-Public: (01)10886982154651
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K112583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 214.832
• Device Catalogue Number: 214.832
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 06/10/2022
• 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: 4.5 VACRVD CONDY PL/12H/266/LT; 4.5MM CORTEX SCREW SELF-TAPPING 32MM; 4.5MM CORTEX SCREW SELF-TAPPING 32MM; 4.5MM CORTEX SCREW SELF-TAPPING 32MM; 5.0 VA LCK SCRW/S/TAP /80; 5.0 VA LOCKNG SCR SLF-TPNG/SD/80; 5.0 VA LOCKNG SCR SLF-TPNG/SD/80; 5.0 VA LOCKNG SCR SLF-TPNG/SD/80; 5.0 VA LOCKNG SCR SLF-TPNG/SD/80; 5.0 VA LOCKNG SCR SLF-TPNG/SD/80; 5.0 VA LOCKNG SCR SLF-TPNG/SD/80
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 24 YR
• Patient Sex: Male