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

Catalog Number	52020304
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	08/22/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3010667733-2023-00548
• Device Sequence Number: 7182703
• Product Code: HRS
• UDI-Device Identifier: 00840420185426
• UDI-Public: 00840420185426
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K163039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 52020304
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Unknown