MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM CORTEX SCREW SELF-TAPPING 34MM; SCREW, FIXATION, BONE

Model Number	204.834
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient¿s gender and weight are unknown.Date of event is unknown.Additional device product codes: hrs, jds.Device broke during insertion; device not considered implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 tibial plateau procedure on an unknown date.While implanting a 3.5 mm cortex screw for the procedure, the head of the screw snapped off in the patient.The shaft of the screw could not be recovered.The surgeon believed that there was no issue leaving the shaft in the patient.The surgical delay and patient outcome were unknown.There was no additional information provided.Concomitant device reported: unknown tibial plate (part # unknown, lot # unknown, quantity 1).This is report 1 of 1 for complaint (b)(4).

• Brand Name: 3.5MM CORTEX SCREW SELF-TAPPING 34MM
• 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: 7548665
• Report Number: 2939274-2018-52326
• Device Sequence Number: 1697936
• Product Code: HWC
• UDI-Device Identifier: 10886982146359
• UDI-Public: (01)10886982146359
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K131186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/03/2018

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: 204.834
• Device Catalogue Number: 204.834
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 05/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR