MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5MM CORTEX SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 16MM; SCREW, FIXATION, BONE

Model Number	02.214.116
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device product code: hrs.Device broke intra-operatively and was not fully implanted or explanted.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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.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 on (b)(6 2019, the patient underwent open reduction internal fixation (orif) of the metacarpals.While covering a case, one (1) 1.5mm/16mm cortex screw self tapping and one (1) 1.5mm/12mm cortex screw self tapping broke while inserting and as well as one (1) drill bit broke.Screw heads snapped off and surgeon burred the screw down so it was flush.A drill bit also broke.There were fragments generated from broken device but was not easily removed.The surgeon attempted to remove the screw with some pliers and could not get it out and chose to burr the proud portion of the screw so the fragment was flush with bone.The procedure was successfully completed with 15 - 20 minutes surgical delay.Patient status is unknown.This report is for one (1) 1.5mm cortex screw self tapping 16mm.This is report 1 of 3 for complaint (b)(4).

• Brand Name: 1.5MM CORTEX SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 16MM
• 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: 8680008
• Report Number: 2939274-2019-58547
• Device Sequence Number: 2114978
• Product Code: HWC
• UDI-Device Identifier: 10886982055507
• UDI-Public: (01)10886982055507
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/10/2019

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: 02.214.116
• Device Catalogue Number: 02.214.116
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2019
• Initial Report FDA Received Date: 06/07/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention