MAUDE Adverse Event Report: SYNTHES GMBH 11MM/125 DEG TI CANN TFNA 235MM/LEFT ¿ STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.037.115S

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Type  Injury  

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 11mm/125 deg ti cann tfna 235mm/left - sterile.This is report 1 of 2 for (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.(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.

• Brand Name: 11MM/125 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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14714667
• MDR Text Key: 294946673
• Report Number: 8030965-2022-04075
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819650299
• UDI-Public: (01)07611819650299
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.115S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2022
• Initial Date FDA Received: 06/16/2022
• 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 HELICAL BLADE PERF L90 TAN; TRAUMACEM V+ CEMENT KIT 10 ML
• Patient Outcome(s): Required Intervention
• Patient Sex: Female