MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.3MM CORTEX SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 8MM; SCREW, FIXATION, BONE

Model Number	02.130.008
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient id also reported as (b)(6).Additional procode: hrs.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 on (b)(6) 2020, the surgeon was using a variable angle (va) handset to put in lag screws and one 1.3 cortex screw.While the surgeon was inserting the screw, the 1.3 cortex screw broke at the head.The surgeon left the broken portion of the screw in the patient and added another screw to ensure stability.There was a less than 5 minute surgical delay.The procedure was completed successfully.This report involves 1 1.3mm cortex screw slf-tpng with stardrive recess 8mm.This is report 1 of 1 for (b)(4).

• Brand Name: 1.3MM CORTEX SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 8MM
• 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: 9922635
• Report Number: 2939274-2020-01692
• Device Sequence Number: 19665551
• Product Code: HRS
• UDI-Device Identifier: 10886982044143
• UDI-Public: (01)10886982044143
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K150099
• 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): 03/10/2020

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: 02.130.008
• Device Catalogue Number: 02.130.008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 04/03/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention