MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP PLATE 12 HOLES 163MM; PLATE, FIXATION, BONE

Model Number 223.621

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Additional product codes: hwc, ktt.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 on (b)(6) 2018, the patient underwent a hardware removal of one (1) unknown 3.5 mm locking screw that was broken and one (1) unknown 5mm cannulated locking screw that was cold welded to 4.5mm locking compression plate (lcp) proximal tibia plate 12 holes/226mm left due to infection.The plate had to be cut away to remove the screw.All implants including three (3) unknown 5.0 mm cannulated screws, six (6) unknown locking screws, four (4) unknown cortex screws, (1) unknown locking screw, and one (1) unknown cannulated screw were removed successfully.There was difficulty removing the fragments that were generated from the broken device and trephine was used to remove the screw head.Original implantation was on (b)(6) 2015, for an open reduction and internal fixation (orif) of the proximal tibia.The procedure was completed successfully.There was no surgical delay.The patient outcome was stable.This complaint captures the post-operative infection and broken screws.The intra-operative event involving the plate being cut away is captured under related complaint (b)(4).This report is for a 12-hole locking compression plate.This is report 2 of 7 for (b)(4).

• Brand Name: 3.5MM LCP PLATE 12 HOLES 163MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8196923
• MDR Text Key: 131417728
• Report Number: 2939274-2018-55574
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982158031
• UDI-Public: (01)10886982158031
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082807
• 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: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 223.621
• Device Catalogue Number: 223.621
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2018
• 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 Age: 48 YR
• Patient Weight: 72