MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM TI CORTEX SCREW SELF-TAPPING 55MM; SCREW, FIXATION, BONE

Model Number	402.855
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional pro code: 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.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 an open reduction and internal fixation (orif) of the right femur on (b)(6) 2018, the surgeon pulled the cortex screw out of the screw rank and noticed that there were no screw recess cuts made in the screw head.Another cortex screw was used.Procedure was completed without any issue.Patient outcome is unknown.This report is for a 2.7mm titanium (ti) cortex screw.This is report 1 of 1 for (b)(4).

• Brand Name: 2.7MM TI CORTEX SCREW SELF-TAPPING 55MM
• 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: 8055296
• Report Number: 2939274-2018-54914
• Device Sequence Number: 1833540
• Product Code: HWC
• UDI-Device Identifier: 10886982206671
• UDI-Public: (01)10886982206671
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 10/24/2018

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: 402.855
• Device Catalogue Number: 402.855
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 11/09/2018
• Patient Sequence Number: 1