MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM CORTEX SCREW SELF-TAPPING 40MM; SCREW, FIXATION, BONE

Model Number	214.840
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code: ktt.Device malfunctioned intra-operatively and was not 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.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.(b)(4).
Event or Problem Description
It was reported that the head of a 4.5mm cortex screw broke off during a retrograde nailing of midshaft open femur fracture on (b)(6) 2018.The screw hit the femoral nail as the surgeon was inserting the screw in the femur; the head of the screw broke off.A considerable amount of time was spent performing fluoroscopy and attempting to retrieve the screw.The threads of the screw were removed.The head of the screw could be seen on fluoroscopy but was deep in the quadricep muscle and could not be retrieved without harming the patient.The surgery was successfully completed with patient outcome as expected.Concomitant device reported: retrograde femoral nail (part number unknown, lot number unknown, quantity 1).This report is for one (1) 4.5mm cortex screw self-tapping 40mm.This is report 1 of 1 for (b)(4).

• Brand Name: 4.5MM CORTEX SCREW SELF-TAPPING 40MM
• 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: 7520238
• Report Number: 2939274-2018-52214
• Device Sequence Number: 11145264
• Product Code: HWC
• UDI-Device Identifier: 10886982154699
• UDI-Public: (01)10886982154699
• Combination Product (Y/N): N
• PMA/510(K) Number: K112583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/23/2018

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: 214.840
• Device Catalogue Number: 214.840
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/23/2018
• Initial Report FDA Received Date: 05/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention