MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5MM CORTEX SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 11MM; SCREW, FIXATION, BONE

Model Number	02.214.111
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is an unknown date in 2019.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.(b)(4).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 a procedure on an unknown date, while the surgeon was putting a cortex screw self-taping into the plate, the head of cortex screw snapped off.The surgeon switched to a stronger plate and screw 2.0mm construct and completed the case.Fragments were generated from the broken device.The surgeon tried extracting the shaft of screw but opted to leave it in because it was so tiny; the surgeon was unable to grip it to get it out.The surgeon then oriented the larger plate over the fragment.Procedure was successfully completed with a surgical delay of three to four (3-4) minutes.Patient outcome is unknown.No revision surgery is planned.Concomitant devices: variable angle locking y-plate (part: 02.130.253, lot: unknown, quantity: 1).This report is for a 1.5mm cortex screw self-tapping.This is report 1 of 1 for (b)(4).

• Brand Name: 1.5MM CORTEX SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 11MM
• 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: 8941776
• Report Number: 2939274-2019-60178
• Device Sequence Number: 2609620
• Product Code: HWC
• UDI-Device Identifier: 10886982055453
• UDI-Public: (01)10886982055453
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 07/31/2019

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: 02.214.111
• Device Catalogue Number: 02.214.111
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 08/28/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention