MAUDE Adverse Event Report: SYNTHES MONUMENT 10MM/130 DEG TI CANN TFNA 440MM/LEFT - STERILE; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.037.065S

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problems Failure of Implant (1924); Sedation (2368)

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.(b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.Manufacturing location: (b)(4).Manufacturing date: november 25, 2014.Expiration date: september 30, 2024.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Sterility documentation was reviewed and determined to be conforming.The event as per complaint description cannot be associated with the sterility process of the product.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

It is reported patient presented with a left subtrochanteric hip fracture on (b)(6) 2015 and was implanted with open reduction and internal fixation (orif)at the left femur, the trochanteric femoral nail-advanced (tfna) and helical blade with distal screws and cables on that same date.It is reported patient suffered multiple falls and, during a follow up visit to the surgeon on (b)(6) 2016, it was noted the nail had broken where it intersects with the helical blade.It is not known how this was discovered.Patient was returned to surgery on (b)(6) 2016 where surgeon removed the nail and blade and revised patient to orif of the left femur.It is further reported removal of the nail and blade was difficult, causing a delay of more than thirty (30) minutes.Procedure was completed successfully.Concomitant devices reported: helical blade (part 04.038.300s, lot 7811884, quantity 1), screw (part and lot unknown, quantity unknown), cable (part and lot unknown, quantity unknown) this is report 1 of 1 for (b)(4).

• Brand Name: 10MM/130 DEG TI CANN TFNA 440MM/LEFT - STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5816045
• MDR Text Key: 50237962
• Report Number: 1719045-2016-10566
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.065S
• Device Lot Number: 7821575
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNKNOWN SCREW
• Patient Outcome(s): Required Intervention
• Patient Weight: 103