MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM CORTEX SCREW SELF-TAPPING 36MM; SCREW, FIXATION, BONE

Model Number	214.836
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional device code: ktt.Device broke during insertion; device not considered implanted/explanted.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 the patient underwent a proximal femur fracture fixation procedure with 95 degree condylar blade plate on (b)(6) 2019.Upon insertion of the cortex screw self-tapping, the head broke off.The surgeon removed the broken head easily and the shaft of the screw was retained in the patient.The procedure was successfully completed with no surgical delay.Concomitant device reported: unk - condylar plate (part# unknown, lot# unknown, quantity# 1).This report is for one (1) 4.5mm cortex screw.This is report 1 of 1 for (b)(4).

• Brand Name: 4.5MM CORTEX SCREW SELF-TAPPING 36MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8437146
• Report Number: 2939274-2019-57044
• Device Sequence Number: 19393561
• Product Code: HWC
• UDI-Device Identifier: 10886982154675
• UDI-Public: (01)10886982154675
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K161616
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 214.836
• Device Catalogue Number: 214.836
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 03/20/2019
• Patient Sequence Number: 1
• Patient Age: 36 YR