MAUDE Adverse Event Report: SYNTHES GMBH 10MM/130 DEG TI CANN TFNA 235MM/LEFT - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.037.045S

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.Without a lot number the device history records review could not be completed.Product was not returned.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: it was reported that, during a procedure the proximal femoral nailing system(tfna) was broke at the distal locking hole.The distal fragment of the nail was not retrievable, as it was pushed as far distal in the femur as possible and a new tfna was implanted.Concomitant devices reported: unknown nail head elements: tfna helical blade (part# unknown, lot# unknown, quantity# 1).Unknown screws: locking: trauma (part# unknown, lot# unknown, quantity# unknown).Unknown end cap (part# unknown, lot# unknown, quantity 1).This report is for (1) tfna fem nail ø9 le 130° l235 timo15.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 10MM/130 DEG TI CANN TFNA 235MM/LEFT - STERILE
• 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: 12751697
• MDR Text Key: 280131738
• Report Number: 8030965-2021-09307
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819649972
• UDI-Public: (01)07611819649972
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.045S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - END CAPS: TFNA; UNK - NAIL HEAD ELEMENTS: HELICAL BLADE; UNK - SCREWS: LOCKING; UNK - END CAPS: TFNA; UNK - NAIL HEAD ELEMENTS: HELICAL BLADE; UNK - SCREWS: LOCKING