MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM CANNULATED SCREW PARTIALLY THREADED/42MM; SCREW, FIXATION, BONE

Model Number	214.542
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/18/2019
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.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 internal fixation (orif) of the tibial tubercle on (b)(6) 2019, the 4.5 cannulated screw was placed into the patient and the thread came off.The surgeon stated that he believed the thread came off due to extremely hard bone and that he did not pre drill.During screw insertion the thread of the screw unwound off the core of the screw.No attempts were made to retrieve the fragment.Device was left in the patient.Procedure was successfully completed with no surgical delay.Patient outcome was good.Concomitant devices: plate (part: unknown, lot: unknown, quantity: 1).This report is for a 4.5mm cannulated screw.This is report 1 of 1 for (b)(4).

• Brand Name: 4.5MM CANNULATED SCREW PARTIALLY THREADED/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: 9280538
• Report Number: 2939274-2019-61981
• Device Sequence Number: 14136756
• Product Code: HWC
• UDI-Device Identifier: 10886982154170
• UDI-Public: (01)10886982154170
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K161616
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/19/2019

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: 214.542
• Device Catalogue Number: 214.542
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2019
• Initial Report FDA Received Date: 11/05/2019
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Weight: 61