MAUDE Adverse Event Report: SYNTHES GMBH 9MM/125 DEG TI CANN TFNA 200MM - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.037.913S

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.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2022, the patient underwent an open reduction internal fixation surgery for trochanteric fracture of femur.The surgery was completed successfully with no surgical delay.After surgery, on unknown date, the patient fell and had a secondary fracture.The event was not reported to be product related.The revision surgery is planned on (b)(6) 2022.In the revision surgery, the trochanteric fixation nail advanced (tfna) used in the initial surgery was removed and a new longer nail and cement was used for treatment.It was further noted, the tfna was broken.It is unknown if the nail broke during fall.This report is for a tfna.This is report 1 of 3 for (b)(4).

• Brand Name: 9MM/125 DEG TI CANN TFNA 200MM - 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: 13835427
• MDR Text Key: 292600612
• Report Number: 8030965-2022-01769
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819651715
• UDI-Public: (01)07611819651715
• 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
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.913S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2022
• 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 - NAIL HEAD ELEM: TFNA HELICAL BLADE; UNK - SCREWS: NAIL DISTAL LOCKING
• Patient Outcome(s): Required Intervention