MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 14MM; PLATE, FIXATION, BONE

Model Number	201.364.97
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event reported as 2018, exact date is not known.(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 patient underwent an open reduction internal fixation (orif) of the radial neck/head utilizing the variable angle (va) locking y-plate on (b)(6) 2018.It was further reported the fixation did not hold.Patient was returned to surgery on (b)(6) 2018 where surgeon removed the y-plate, four (4) va locking screws and four (4) cortex screws.This report is for one (1) 2.0mm cortex screw.This is report 4 of 9 for (b)(4).

• Brand Name: 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 14MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8037532
• Report Number: 2939274-2018-54769
• Device Sequence Number: 11088436
• Product Code: HRS
• UDI-Device Identifier: 10886982141897
• UDI-Public: (01)10886982141897
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K063049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/19/2018

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: 201.364.97
• Device Catalogue Number: 201.364.97
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 11/05/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 68