MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RFNA/ 12MM/ 420MM/ STANDARD BEND/ STER; SCREW, FIXATION, BONE

Model Number	04.233.242S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.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 an unknown date, the nail broke just above the juncture where medial/lateral oblique screw heads sit in distal aspect of nail.It is unknown when the issue was observed.Patient consequences are unknown.This report is for one (1) rfna/ 12mm/ 420mm/ standard bend/ ster.This is report 1 of 1 for complaint (b)(4).

• Brand Name: RFNA/ 12MM/ 420MM/ STANDARD BEND/ STER
• 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: 15129110
• Report Number: 2939274-2022-03013
• Device Sequence Number: 6481595
• Product Code: HWC
• UDI-Device Identifier: 10886982290908
• UDI-Public: (01)10886982290908
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K201346
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/29/2022

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: 04.233.242S
• Device Catalogue Number: 04.233.242S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2022
• Initial Report FDA Received Date: 07/29/2022
• 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: 3.5 VA LCKNG SCR SLF-TPNG/SD/75; 3.5 VA LCKNG SCR SLF-TPNG/SD/80; 3.5 VA LCKNG SCR SLF-TPNG/SD/85; 3.5 VA LCKNG SCR SLF-TPNG/SD/90; 5.0 VAL SCREOPTILINK(TM) SLF-TPNG/SD/85; LCKNG ATTACH WASHER RFNA / 5 DEG/ RT/ S; LOCKSCR F/MEDULLARY NAIL Ø5 L36 XL25; LOCKSCR F/MEDULLARY NAIL Ø5 L74 XL25
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown