MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM TI CORTEX SCREW SELF-TAPPING 12MM; SCREW, FIXATION, BONE

Model Number	401.512.96
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
Date of event is unknown.Additional procode: jey.Lot number is unknown.Device malfunctioned intra-operatively and was not implanted / explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter last name and email address are unknown.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 an open reduction internal fixation (orif) for metacarpal procedure on (b)(6) 2018.The surgeon implanted a 2.4mm plate.As the surgeon attempted to insert the screw, it was noticed that the lining of the screw was peeling.The screw and the screw lining pieces were removed from the patient and discarded.A new screw was used to complete the procedure.The procedure was completed successfully with no surgical delay.Patient was stable.Concomitant device: 2.4mm plate (part: unknown, lot: unknown, quantity: 1).This report is for a 2.4mm titanium (ti) cortex screw self-tapping 12mm.This is report 1 of 1 for (b)(4).

• Brand Name: 2.4MM TI CORTEX SCREW SELF-TAPPING 12MM
• 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: 7808528
• Report Number: 2939274-2018-53437
• Device Sequence Number: 13837012
• Product Code: HWC
• UDI-Device Identifier: 10886982204349
• UDI-Public: (01)10886982204349
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/03/2018

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: 401.512.96
• Device Catalogue Number: 401.512.96
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2018
• Initial Report FDA Received Date: 08/23/2018
• Patient Sequence Number: 1