MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC MTP FUSION SMALL 10DG RT ORTHOLOC 3DI PLATING SYSTEM; PLATE, FIXATION, BONE

Model Number 587111RT

Device Problem Material Fragmentation (1261)

Patient Problems Granuloma (1876); Pain (1994)

Event Date 04/13/2023

Event Type  Injury  

Event Description

The ortholoc system, composed of plates and screws, used for arthrodesis of the first ray of the foot for hallux rigidus, released a metal fragment which caused a foreign body granuloma in the soft tissue.This was noticed post-op on x-ray due to presence of pain.Surgery was necessary to remove the granuloma, the metal fragment was identified inside it.

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.H3 other text : device not available.

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.

Event Description

The ortholoc system, composed of plates and screws, used for arthrodesis of the first ray of the foot for hallux rigidus, released a metal fragment which caused a foreign body granuloma in the soft tissue.This was noticed post-op on x-ray due to presence of pain.Surgery was necessary to remove the granuloma, the metal fragment was identified inside it.

• Brand Name: MTP FUSION SMALL 10DG RT ORTHOLOC 3DI PLATING SYSTEM
• 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: 17058626
• MDR Text Key: 316494085
• Report Number: 3010667733-2023-00307
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00840420126511
• UDI-Public: 00840420126511
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K120359
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 08/18/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 587111RT
• Device Catalogue Number: 587111RT
• Device Lot Number: 1616998
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/09/2023
• Initial Date FDA Received: 06/05/2023
• Supplement Dates Manufacturer Received: 07/25/2023
• Supplement Dates FDA Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2017
• 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: 63 YR