MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM CORTEX SCREW SELF-TAPPING 42MM; SCREW, FIXATION, BONE

Model Number	214.842
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional device product code: ktt.Without a valid 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.Information reported on maude report: device broke during insertion; device not considered implanted.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.Mw5083617.
Event or Problem Description
This report is against maude report medwatch number mw5083617.The only information contained in this report is correction or additional information.Concomitant device reported: unk - screws: trauma (part # unknown, lot # unknown, quantity # unknown).This is report 1 of 1 for (b)(4).

• Brand Name: 4.5MM CORTEX SCREW SELF-TAPPING 42MM
• 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: 8430283
• Report Number: 2939274-2019-57017
• Device Sequence Number: 16551261
• Product Code: HWC
• UDI-Device Identifier: 10886982154705
• UDI-Public: (01)10886982154705
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161616
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/21/2019

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: 214.842
• Device Catalogue Number: 214842
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 03/18/2019
• Patient Sequence Number: 1