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

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

This report is for an unk - screws: cortex/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number the device history records review could not be completed.Product was not returned.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 removal due to a non-union and two (2) unknown broken cortex screws in the distal portion of the lateral plate that was removed.Initially, the patient had implantation on an unknown date.Removal of plates and screws due to non-union and revision.Token screws and all hardware were successfully removed including a variable-angle locking compression plate (va-lcp) proximal tibia plate, locking compression plate (lcp) posteromedial proximal tibia plate, locking compression plate (lcp) plate, seven (7) unknown 3.5 mm variable-angle (va) locking screws, three (3) unknown 3.5mm locking screws, three (3) unknown 3.5mm cortex screws, and four (4) unknown 2.4 mm locking screws with no issue.After all, three (3) unknown plates were removed, a 4.5 unknown lateral proximal tibia plate was placed to help hold stability.It is unknown if there was surgical delay.There was no patient consequence.Concomitant devices reported: variable-angle locking compression plate (va-lcp) proximal tibia plate (part# 02.127.231, lot# 9261708, quantity 1), locking compression plate (lcp) posteromedial proximal tibia plate (part# 02.120.702, lot# l345610, quantity 1), locking compression plate (lcp) plate (part# 247.375, lot# unknown, quantity 1), unknown 3.5 mm variable-angle (va) locking screws(part# unknown, lot# unknown, quantity 7), unknown locking screws (part# unknown, lot# unknown, quantity 3), unknown 3.5mm cortex screws (part# unknown, lot# unknown, quantity 1), and unknown 2.4 mm locking screws (part# unknown, lot# unknown, quantity 4).This is report 1 for 2 (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.Complainant part is not expected to be returned for manufacturer review/investigation.Patient code 2199 updated to 3191 to capture fracture nonunion, surgical intervention, and medical device removal.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: CORTEX
• 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: 9147445
• MDR Text Key: 166349480
• Report Number: 2939274-2019-61130
• 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: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2019
• Patient Sequence Number: 1
• Treatment: 2.4MM LCP(TM) PLATE 5 HOLES 44MM; 3.5MM LCP POSTEROMEDIAL PROXIMAL TIBIA PLATE; 3.5MM VA-LCP PROX TIBIA PLATE; UNK - 2.4 MM LOCKING SCREWS; UNK - 3.5 MM VARIABLE-ANGLE (VA) LOCKING SCREWS; UNK - SCREWS: CORTEX; UNK - SCREWS: LOCKING
• Patient Age: 57 YR
• Patient Weight: 89