MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CABLE/WIRE ACCESSORIES: ORTHOPAEDIC CABLE; WIRE, SURGICAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/ investigation.This report is for an unknown cable/ wire accessories: orthopaedic cable/ unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.(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 Description

It was reported that on an unknown date, the patient underwent hardware removal and conversion to total hip due to trochanteric fixation nail advanced (tfna) lag screw that cut out of the femoral head.All hardware was removed easily.The lag screw was pulled out without disengaging the built in locking mechanism.Upon removal, it did not appear any hardware was broken.The infection has not been ruled out.Many tissue samples and hardware samples were sent for evaluation within the hospital pathology department.The procedure and patient outcomes are unknown.Concomitant devices reported: tfna nail (part # unknown, lot # unknown, quantity unknown), end caps (part # unknown, lot # unknown, quantity unknown), locking screw (part # unknown, lot # unknown, quantity unknown), lag screw (part # unknown, lot # unknown, quantity unknown).This report is for one (1) unknown cable/ wire accessories: orthopaedic cable.This is report 5 of 5 for complaint (b)(4).

• Brand Name: UNK - CABLE/WIRE ACCESSORIES: ORTHOPAEDIC CABLE
• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9707221
• MDR Text Key: 180802073
• Report Number: 2939274-2020-00816
• Device Sequence Number: 1
• Product Code: LRN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2020
• 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 Outcome(s): Required Intervention
• Patient Weight: 95