MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC LOCKING SCREW 3.5 X 14MM ORTHOLOC 3DI PLATING SYSTEM; SCREW, FIXATION, BONE

Model Number	58803514
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Granuloma (1876); Pain (1994)
Date of Event	04/13/2023
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem 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.
Event or Problem 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.
Additional 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.

• Brand Name: LOCKING SCREW 3.5 X 14MM ORTHOLOC 3DI PLATING SYSTEM
• Common Device Name: SCREW, 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: 17060002
• Report Number: 3010667733-2023-00309
• Device Sequence Number: 8511177
• Product Code: HWC
• UDI-Device Identifier: 00840420113009
• UDI-Public: 00840420113009
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K102429
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Lay User/Patient
• Device Model Number: 58803514
• Device Catalogue Number: 58803514
• Device Lot Number: 1724527
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/09/2023
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2022
• 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: 63 YR
• Patient Sex: Unknown