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

Model Number 214.542

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 10/18/2019

Event Type  malfunction  

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 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
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9280538
• MDR Text Key: 197178353
• Report Number: 2939274-2019-61981
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886982154170
• UDI-Public: (01)10886982154170
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 214.542
• Device Catalogue Number: 214.542
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Weight: 61