MAUDE Adverse Event Report: ORTHOFIX MEDICAL INC CONNECTOR SYSTEM; SIDE/SIDE LOADING CONNECTOR

Model Number 79-2115

Device Problem Fracture (1260)

Patient Problem Implant Pain (4561)

Event Date 12/16/2022

Event Type  malfunction  

Manufacturer Narrative

Additional information and the return of the device has been requested.A review of the lot history records has been conducted and the device met all design specification.

Event Description

Information provided states that patient experienced pain and recovery was not as expected.A revision surgery was performed and it was found that the connector at l2-3 was broken.

Event Description

Device was returned for investigation.

Manufacturer Narrative

The side/side loading connector (pn: 79-2115 ln: p02) was returned for investigation.The cause of the complaint is related to commencement of set screw tightening prior to ensuring that the rod is fully seated inside the slot of the connector.It was established that the connector fails (yielding to breaking) in the range of 35 to 45 in-lbf, which is well below the 57 in-lbf lower spec limit of the torque wrench in the system.Connector system afmea has already covered this "use related" failure mode with suitable labeling mitigation included in the op tech.A review of the product dhr showed that all inspections met design specifications.A review of ncmr databases did not reveal any non-conformances related to this investigation.

• Brand Name: CONNECTOR SYSTEM
• Type of Device: SIDE/SIDE LOADING CONNECTOR
• Manufacturer (Section D): ORTHOFIX MEDICAL INC; 3451 plano parkway; lewisville TX 75056
• Manufacturer (Section G): ORTHOFIX MEDICAL INC; 3451 plano parkway; lewisville TX 75056
• Manufacturer Contact: ehab esmail ; 3451 plano parkway; lewisville, TX 75056 ; 2149372015
• MDR Report Key: 16442809
• MDR Text Key: 310257472
• Report Number: 2183449-2022-00006
• Device Sequence Number: 1
• Product Code: NKG
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: K172194
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 79-2115
• Device Lot Number: P02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2019
• 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): Other
• Patient Age: 59 YR
• Patient Sex: Male