MAUDE Adverse Event Report: SYNTHES MONUMENT 11MM/130 DEG TI CANN TFNA 400MM/RIGHT - STERILE; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.037.160S

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).Patient weight is not available for reporting.Date of event: unknown.(b)(4).(therapy date): date of implant is unknown.The subject device is not expected to be returned to the synthes manufacturer for evaluation.A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture or sterilization of the product that would contribute to this complaint condition.No non-conformances were generated during the production or sterilization of the subject device.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 revision surgery was performed on (b)(6) 2016 due to a broken unknown 130 degree trochanteric femoral nail-advanced (tfna)-right.The nail broke at the intersection of the nail and helical blade on an unknown date.The surgeon reported that the patient was non-compliant.It is also not known when the tfna system was initially implanted.During the (b)(6) 2016 revision surgery, during the removal of the helical blade, the locking mechanism of the nail broke off and fell into the patient.The surgeon was unable to retrieve the locking mechanism from the patient.The rest of the nail, helical blade and locking screw were removed and the patient and the patient was revised to a competitor's construct.There was no surgical delay and the surgery successfully completed.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This complaint addresses the need for the revision surgery due to the broken nail.See related complaint (b)(4) which addresses and reports the issue with the tfna locking mechanism.(b)(4).

• Brand Name: 11MM/130 DEG TI CANN TFNA 400MM/RIGHT - 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: 5673753
• MDR Text Key: 45719799
• Report Number: 1719045-2016-10429
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK131548
• 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,Followup
• Report Date: 05/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.160S
• Device Lot Number: 9846221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ONE UNKNOWN HELICAL BLADE
• Patient Outcome(s): Required Intervention