MAUDE Adverse Event Report: SYNTHES GMBH TFNA FENESTRATED HELICAL BLADE 90MM - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.038.390S

Device Problem Migration (4003)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: patient id reported as (b)(6).Additional procode: ktt complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).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 australia reports an event as follows: it was reported that patient was treated on (b)(6) 2020, for nof fracture with a trochanteric fixation nail advanced (tfna) 235mm nail, blade, and was augmented with traumacem.On (b)(6) 2021, the patient presented to clinic with progressive lateral thigh pain which had increased over the last twelve months.Upon imaging, the initial nof fracture appears to be healed but the tfna nail had fractured at the proximal aperture and the blade had migrated laterally.As of (b)(6) 2022, the patient still had lateral thigh pain but did not want further operations to remove the implants.This report is for a tfna fenestrated helical blade 90mm - sterile.This is report 2 of 2 for (b)(4).

• Brand Name: TFNA FENESTRATED HELICAL BLADE 90MM - STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14714720
• MDR Text Key: 294936694
• Report Number: 8030965-2022-04077
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819652576
• UDI-Public: (01)07611819652576
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 06/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.390S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2022
• 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: TFNA FEM NAIL Ø11 LE 125° L235 TIMO15; TRAUMACEM V+ CEMENT KIT 10 ML
• Patient Outcome(s): Required Intervention
• Patient Sex: Female