MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 24MM; SCREW, FIXATION, BONE

Model Number	202.884
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional patient identifier: (b)(6).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.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) 2018, during an open reduction and internal fixation (orif) of a pilon, the head of the cortex screw snapped off under power.The resident thought, that it was due to the angle at which it was contacted on unknown plate and was over tightened.The head of the cortex screw was removed, and the remaining portion was retained in the bone.Procedure was completed successfully with no surgical delay reported.Patient outcome is stable.Concomitant device reported: 2.4/2.7mm va-lcp t-fusion plate (part#: 02.211.265, lot# unknown, quantity 1).This report is for one (1) 2.7mm cortex screw.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 24MM
• 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: 8106789
• Report Number: 2939274-2018-55110
• Device Sequence Number: 16711114
• Product Code: HWC
• UDI-Device Identifier: 10886982145116
• UDI-Public: (01)10886982145116
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K113364
• 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): 11/07/2018

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: 202.884
• Device Catalogue Number: 202.884
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 11/27/2018
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 79