MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LCP ONE-THIRD TUB PL COLLAR 12 H/141; PLATE,FIXATION,BONE

Model Number 241.421

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

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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, a surgeon will be removing synthes plates and screws and a fibulink device from an unknown patient on (b)(6) 2021.The reason for the removal is painful hardware.No further information is available.This complaint involves ten(10) devices.This report is for (1) lcp one-third tub pl collar 12 h/141.This report is 1 of 10 for (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- this complaint is not confirmed as no issues were identified on the complaint device that would contribute to the adverse event.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed no definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history review: a manufacturing record evaluation could not be performed as the lot number could not be determined from the image.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: LCP ONE-THIRD TUB PL COLLAR 12 H/141
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12331725
• MDR Text Key: 266895582
• Report Number: 2939274-2021-04699
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982166982
• UDI-Public: (01)10886982166982
• Combination Product (y/n): N
• PMA/PMN Number: K011335
• 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: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 241.421
• Device Catalogue Number: 241.421
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2021
• Patient Sequence Number: 1
• Treatment: FIBULINK® SYNDESMOSIS REPAIR KIT/SS.; UNK - SCREWS: 3.5 MM CORTEX.; UNK - SCREWS: 3.5 MM CORTEX.; UNK - SCREWS: 3.5 MM CORTEX.; UNK - SCREWS: 3.5 MM CORTEX.; UNK - SCREWS: 3.5 MM CORTEX.; UNK - SCREWS: 3.5 MM CORTEX.; UNK - SCREWS: 3.5 MM CORTEX.; UNK - SCREWS: LOCKING.; FIBULINK® SYNDESMOSIS REPAIR KIT/SS; UNK - SCREWS: 3.5 MM CORTEX; UNK - SCREWS: 3.5 MM CORTEX; UNK - SCREWS: 3.5 MM CORTEX; UNK - SCREWS: 3.5 MM CORTEX; UNK - SCREWS: 3.5 MM CORTEX; UNK - SCREWS: 3.5 MM CORTEX; UNK - SCREWS: 3.5 MM CORTEX; UNK - SCREWS: LOCKING
• Patient Outcome(s): Required Intervention