MAUDE Adverse Event Report: GRAHAM MEDICAL TECHNOLOGIES, LLC DBA GRAMEDICA OPTI-TOE; INTRAMEDULLARY PIN

Model Number OT-SS

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

User claimed malfunction.Stated it was not dropped or user error.Claimed it failed to engage properly.Device not returned.

Event Description

Device malfunctioned.

• Brand Name: OPTI-TOE
• Type of Device: INTRAMEDULLARY PIN
• Manufacturer (Section D): GRAHAM MEDICAL TECHNOLOGIES, LLC DBA GRAMEDICA; 16137 leone dr; macomb MI 48042 4063
• Manufacturer (Section G): MICRO MACHINE COMPANY LLC; 2429 n burdick; kalamazoo MI 49007
• Manufacturer Contact: angela recchia ; 16137 leone drive; macomb, MI 48042-4063 ; 5866779600
• MDR Report Key: 15479228
• MDR Text Key: 306357288
• Report Number: 3004993707-2022-00004
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142478
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OT-SS
• Device Catalogue Number: OT-SS
• Device Lot Number: SS061615A2
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1