MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC 4 HOLE STRAIGHT PLATE ORTHOLOC 3DI SMALL BONES; PLATE, FIXATION, BONE

Catalog Number 52020304

Device Problems Break (1069); Fracture (1260)

Patient Problems Failure of Implant (1924); Implant Pain (4561)

Event Date 08/22/2023

Event Type  Injury  

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.H3 other text : device remains implanted in the patient.

Event Description

A patient underwent surgery during which a small bones straight plate (52020304) was implanted.Subsequently, the plate broke, as confirmed by an in-clinic x-ray.The patient approached the physician regarding a potential issue with the product, and the physician saw the patient for further evaluation.The physician believes the patient was compliant with mobilization instructions.The patient noticed the event due to foot pain and sought an x-ray, but the exact date is uncertain.The implant was initially used for a non-displaced 5th metatarsal base fracture (ao classification).The event is currently being managed without a revision procedure, and the patient is using a bone stimulator.

• Brand Name: 4 HOLE STRAIGHT PLATE ORTHOLOC 3DI SMALL BONES
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17848642
• MDR Text Key: 324658306
• Report Number: 3010667733-2023-00548
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00840420185426
• UDI-Public: 00840420185426
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 52020304
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2023
• Initial Date FDA Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR