MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5MM CORTEX SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 10MM; SCREW,FIXATION,BONE

Model Number	02.214.110
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product codes: hrs.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 on (b)(6) 2019, during an open reduction internal fixation (orif) of the second metacarpal, the screw head cut off while the surgeon inserted the cortex screw into a plate.The surgeon had to then remove the plate.There was difficulty removing the other half of the screw in the bone.It was removed using a broken screw removal set.The surgeon then placed the plate back on and finished the procedure with new screws.The procedure was successfully completed with a fifteen (15) minute surgical delay.There were no fragments generated.Patient status is unknown.Concomitant device reported: unknown plate (part#unknown, lot#unknown, quantity 1).This report is for one (1) 1.5mm cortex screw slf-tpng with t4 stardrive recess 10mm.This is report 1 of 1 for (b)(4).

• Brand Name: 1.5MM CORTEX SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 10MM
• 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: 8437374
• Report Number: 2939274-2019-57051
• Device Sequence Number: 2227868
• Product Code: HWC
• UDI-Device Identifier: 10886982055446
• UDI-Public: (01)10886982055446
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 02/26/2019

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: 02.214.110
• Device Catalogue Number: 02.214.110
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 03/20/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 18 YR