MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 38MM-STERILE; APPLIANCE,FIXATION,NAIL

Model Number	412.213S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Malunion of Bone (4529)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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) 2021, the patient underwent hip revision surgery due to malunion and femoral neck collapse.The surgeon removed one (1) femoral neck system plate, one (1) femoral neck bolt, one (1) antirotation femoral neck screw, and one (1) 5mm ti locking screw.The original procedure date is unknown.The hardware was removed with no issues.The patient was then implanted with a hip hemi arthroplasty.The procedure was successfully completed.This report is for one (1) 5.0mm ti locking scr slf-tpng w/t25 stardrive 38mm-sterile.This is report 4 of 4 for (b)(4).

• Brand Name: 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 38MM-STERILE
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11438964
• Report Number: 2939274-2021-01237
• Device Sequence Number: 14337430
• Product Code: KTT
• UDI-Device Identifier: 10886982275400
• UDI-Public: 10886982275400
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K000682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/10/2021

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: 412.213S
• Device Catalogue Number: 412.213S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 03/08/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention