MAUDE Adverse Event Report: SYNTHES GMBH TFNA FEM NAIL Ø10 LE 125° L320 TIMO15; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.037.023S

Device Problem Break (1069)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Event Description

This (b)(4) is related to (b)(4) which reports about the secondary fracture which occurred after the primary surgery.This pc reports about the nail breakage and bone fracture which occurred after healing of secondary fracture.It was reported that on (b)(6) 2021, the patient underwent the primary surgery for the subtrochanteric fracture of femur with the nail in question.The surgery was completed successfully without any surgical delay.After the surgery, the patient had a second bone fracture on (b)(6) 2021.The surgeon followed up with conservative therapy and then union was confirmed.After that, the patient has a third bone fracture and nail breakage on (b)(6) 2022.The affected area fractured again in the middle of the distal locking screw.The revision surgery is planned on (b)(6) 2022.The surgeon commented as follows.The patient had rheumatoid arthritis, and bone quality was poor.Since the location of the fracture as of on (b)(6) 2021 was between the most distal and medial of distal locking screws, which means that the distal bone fragment had been fixed by the most distal screw only.So, the bone union was completed with flexural deformation during the follow-up with conservative therapy, and therefore the nail had been placed in the excessive stressful force probably.No further information is available.This report is for one (1) tfna fem nail ø10 le 125° l320 timo15.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TFNA FEM NAIL Ø10 LE 125° L320 TIMO15
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf ; SZ ; 6103142063
• MDR Report Key: 15074529
• MDR Text Key: 296303464
• Report Number: 8030965-2022-05034
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819649774
• UDI-Public: (01)07611819649774
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.023S
• Device Lot Number: H860146
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 45 KG