MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5 LOW PRO RECONSTRUCTION PL 6 HOLES; SCREW, FIXATION, BONE

Model Number 245.026

Device Problem Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 06/22/2022

Event Type  Injury  

Manufacturer Narrative

Additional narrative: additional product code: 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) 2022, the patient revised the plate due to screws pulling out.It is unknown if there was a surgical delay.Procedure and patient outcome were unknown.There is no further information.This report is for one (1)3.5 low pro reconstruction pl 6 holes.This is report 2 of 7 for complaint (b)(4).

• Brand Name: 3.5 LOW PRO RECONSTRUCTION PL 6 HOLES
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15070672
• MDR Text Key: 296288068
• Report Number: 2939274-2022-02753
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982169396
• UDI-Public: (01)10886982169396
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 245.026
• Device Catalogue Number: 245.026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2022
• 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: 75 YR
• Patient Sex: Female