MAUDE Adverse Event Report: SYNTHES GMBH TFNA FEM NAIL Ø12 R 130° L320 TIMO15; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.037.252S

Device Problem Break (1069)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: this (b)(4) is related to (b)(4) which reports about the pain after the surgery performed on (b)(6) 2021.This (b)(4) reports about the event after the primary surgery.It was reported that 9 years ago, the patient underwent the surgery with the afn implants.Procedure was completed successfully.After the surgery, it was found that the patient had proximal femoral trochanteric comminuted fracture.On (b)(6) 2021, the patient underwent open reduction internal fixation surgery for proximal femoral trochanteric comminuted fracture with the nail in question.The surgeon performed a side-plate reinforcement by using a cement, lcp plate, and cable.Procedure was completed successfully.Concomitant device reported: unk - screw: (part# unknown; lot# unknown; quantity: unknown).This report is for one (1) tfna fem nail ø12 r 130° l320 timo15.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d4.Expiration date.H4.Device manufacture date.H6 - codes updated to imdrf codes.Device history lot - a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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 Ø12 R 130° 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 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12821383
• MDR Text Key: 280831062
• Report Number: 8030965-2021-09545
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819651289
• UDI-Public: (01)07611819651289
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.252S
• Device Lot Number: H046507
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2022
• Date Device Manufactured: 03/31/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - END CAPS: TFNA; UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; UNK - SCREWS: NAIL DISTAL LOCKING
• Patient Age: 66 YR
• Patient Sex: Female