MAUDE Adverse Event Report: SYNTHES MONUMENT 11MM/125 DEG TI CANN TFNA 170MM - STERILE; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.037.112S

Device Problems Fitting Problem (2183); Device Operates Differently Than Expected (2913)

Patient Problems Fall (1848); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Exact date of post-operative blade migration and onset of pain is unknown.(b)(4).Although a revision procedure was performed on (b)(6) 2016, the nail was not explanted.The complainant part is not expected to be returned for manufacturer review/investigation.Investigation could not be completed and no conclusion could be drawn as no device was returned.Device history record review: manufacturing location: (b)(4) - manufacturing date: may 14, 2015 - expiration date: april 30, 2025.No non-conformance reports were generated during production.A 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.The sterility documentation was reviewed and determined to be conforming.Device 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 was reported that a patient underwent a hardware removal procedure on (b)(6) 2016 due to helical blade migration.The patient was originally treated on (b)(6) 2016 during which time a trochanteric fixation nail (tfn) and blade were inserted.It was noted that a screw was not used during this initial procedure.On an unknown post-operative date, the patient suffered a fall and began experiencing pain.X-ray images taken thereafter confirmed that the helical blade had cut out of the nail and migrated into the pelvis.The patient was returned to the operating room where only the blade was removed.Although the surgeon noted that the locking mechanism of the nail appeared to be in the incorrect position, a decision was made to leave the nail in situ.The procedure was completed with no reports of surgical delay or additional intervention.Post-operatively, the patient was noted to be stable.This report is 2 of 2 for (b)(4).

• Brand Name: 11MM/125 DEG TI CANN TFNA 170MM - 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5994576
• MDR Text Key: 56333159
• Report Number: 1719045-2016-10733
• 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: 09/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.112S
• Device Lot Number: 9803946
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention