MAUDE Adverse Event Report: SYNTHES GMBH 10MM/125 DEG TI CANN TFNA 235MM/RIGHT - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.037.014S

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Facility address reported as (b)(6). 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 (b)(6) reports an event as follows: it was reported that patient underwent revision surgery on (b)(6) 2022, date due to a broken nail. A new trochanteric fixation nail advanced (tfna) was placed. Patient was originally treated for subtrochanteric/ intertrochanteric fracture right femur on (b)(6) 2021. Three weeks postoperatively, patient began to feel pain. Procedure was completed successfully. This report is for a 10mm/125 deg ti cann tfna 235mm/right ¿ sterile. This is report 1 of 1 for (b)(4).

• Brand Name: 10MM/125 DEG TI CANN TFNA 235MM/RIGHT - 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: 13518530
• MDR Text Key: 287349467
• Report Number: 8030965-2022-00857
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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

• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 04.037.014S
• Device Lot Number: 204P757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 02/11/2022 Patient Sequence Number: 1

Treatment

UNK - END CAPS: TFNA; UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; UNK - SCREWS: NAIL DISTAL LOCKING