MAUDE Adverse Event Report: UNKNOWN TI-CORTEX SCREW Ø4,5MM; IMPLANT

Catalog Number UNK_SEL

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Pain (1994); Perforation (2001); Hip Fracture (2349); Non-union Bone Fracture (2369)

Event Date 09/02/2021

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device remains in the patient.

Event Description

As reported: "in 2017, internal fixation with twin hook was used for femoral neck fracture and t2 nail was used for femoral supracondylar fracture.Four years postoperatively, the appearance of abdominal pain led to pelvic perforation of the hook pin, pseudoarticulation of the femoral neck, and fracture of the distal screw.Revision surgery was performed, the fractured screws were left in the bone and the hook was removed.There was no internal damage.".

Manufacturer Narrative

***correction: please refer to h6 results & conclusion codes.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the exact root cause of the complaint event.Based on the provided information the device was implanted for four years with a reported non-union which could have played a role on the report event.In this relation, the instruction for use can be pointed out: these devices can break when subjected to the increased loading associated with delayed unions and/or non-unions.Internal fixation devices are load sharing devices which are intended to hold fractured bone surfaces in apposition to facilitate healing.If healing is delayed or does not occur, the appliance may eventually break due to metal fatigue.Loads on the device produced by load bearing and the patient¿s activity level will dictate the longevity of the device.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

As reported: "in 2017, internal fixation with twin hook was used for femoral neck fracture and t2 nail was used for femoral supracondylar fracture.Four years postoperatively, the appearance of abdominal pain led to pelvic perforation of the hook pin, pseudoarticulation of the femoral neck, and fracture of the distal screw.Revision surgery was performed, the fractured screws were left in the bone and the hook was removed.There was no internal damage.".

• Brand Name: UNKNOWN TI-CORTEX SCREW Ø4,5MM
• Type of Device: IMPLANT
• MDR Report Key: 12537501
• MDR Text Key: 273530241
• Report Number: 0008031020-2021-00422
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention