MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS-40MM; SCREW,FIXATION,BONE

Model Number	201.790
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is unknown.Date of event is unknown.Additional classification code: hrs.Implant and explant date is unknown/not applicable.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).Without a lot number the device history records review could not be completed.The manufacture date is unknown.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 during an open reduction internal fixation (orif) procedure on (b)(6) 2018 the head of a 2.4mm cortex screw came off.The screw was placed in the wrong position, and when an attempt was made to remove it the head came off.The surgeon attempted to remove the screw with a screwdriver and when that failed attempted to remove it with a pair of pliers.There was no reported patient consequence, no surgical delay, no fragments and procedure was successfully completed.Concomitant parts: device: 3.5 cortex screw (part number: 204.840, lot number: unknown, quantity: 1), unknown screwdriver (part number: unknown, lot number: unknown, quantity: 1), unknown pliers (part number: unknown, lot number: unknown, quantity: 1).This is report 1 of 1 for (b)(4).

• Brand Name: 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS-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: 7426297
• Report Number: 2939274-2018-51630
• Device Sequence Number: 1274451
• Product Code: HWC
• UDI-Device Identifier: 10886982142887
• UDI-Public: (01)10886982142887(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K112583
• 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): 03/19/2018

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: 201.790
• Device Catalogue Number: 201.790
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 04/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1