MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - SCREWS: LOCKING; SCREW, FIXATION, BONE

Device Problem Device-Device Incompatibility (2919)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 12/07/2019

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown locking screw/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(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 during a revision procedure on (b)(6) 2019, the surgeon was unable to loosen the distal locking screws as it was discovered to have cold welded into the plate.The surgeon have decided to removed it as a whole.The fns plate and screws were successfully removed and the patient was revised to trochanteric fixation nail advanced (tfna) augmentation system.There was a 10 minutes surgical delay reported.Patient status was good.Per surgeon, the device was not placed correctly and the distal locking screws were too posterior which lead to a stress riser that led to fracture.Concomitant device reported: antirotation screw (part # unknown, lot # unknown, quantity 1), bolt (part # unknown, lot # unknown, quantity 1).This report is for one (1) unknown locking screw.This is report 2 of 3 for complaint (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6 investigation summary.The complaint condition of "was unable to loosen the distal locking screws as it was discovered to have cold welded into the plate" could not be confirmed according to the received x-ray.Product was not returned.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: UNK - SCREWS: LOCKING
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9582781
• MDR Text Key: 186727863
• Report Number: 2939274-2020-00158
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/24/2020
• Patient Sequence Number: 1
• Treatment: NECK FIX BOLT L100 TAN.; UNK - NAIL HEAD ELEMENTS: FNS ANTIROTATION.
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 77