MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4/2.7 VA-LOCKING MESH PL/5 X 12 HOLES; PLATE, FIXATION, BONE

Model Number 02.211.224

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

Patient Problem Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: additional product code: hwc.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, the mesh plate was removed from the patient's patella due to discomfort.This report is for one (1) 2.4/2.7 va-locking mesh pl/5 x 12 holes.This is report 1 of 1 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.The complaint condition could not be confirmed during photo/video investigation.During the investigation, no product design issues, or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history lot lot number is unknown, and therefore, dhr could not be completed.If the lot number can be confirmed, the dhr will be revisited.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: 2.4/2.7 VA-LOCKING MESH PL/5 X 12 HOLES
• 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: 12338948
• MDR Text Key: 267150020
• Report Number: 2939274-2021-04719
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982054081
• UDI-Public: (01)10886982054081
• Combination Product (y/n): N
• PMA/PMN Number: K100776
• 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: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.211.224
• Device Catalogue Number: 02.211.224
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/06/2021
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: CORTEX; UNK - SCREWS: LOCKING: VARIABLE ANGLE; UNK - SCREWS: CORTEX; UNK - SCREWS: LOCKING: VARIABLE ANGLE
• Patient Outcome(s): Required Intervention