MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM CORTEX SCREW 56MM; SCREW,FIXATION,BONE

Model Number	214.560
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 on an unknown date that during an open reduction internal fixation (orif) of the left elbow on (b)(6) 2020, while placing a synthes 4.5 cannulated screw, the screw delaminated while placing the screw into the patient's elbow.The procedure was successfully completed with no surgical delay.There was no patient consequence reported.This complaint involves one (1) device.This is report 1 of 1 for (b)(4).

• Brand Name: 4.5MM CORTEX SCREW 56MM
• 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: 9958913
• Report Number: 2939274-2020-01820
• Device Sequence Number: 11488195
• Product Code: HWC
• UDI-Device Identifier: 10886982154255
• UDI-Public: (01)10886982154255
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2020

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: 214.560
• Device Catalogue Number: 214.56
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 04/14/2020
• Patient Sequence Number: 1
• Patient Age: 11 YR
• Patient Weight: 49