MAUDE Adverse Event Report: SYNTHES MONUMENT 10MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 456.315S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Implant procedure was done approximately ten (10) months ago for (b)(6) 2017.Exact date is unknown.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review has been requested.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 was reported on (b)(6) 2017 that approximately ten (10) months ago, patient underwent a repair of a right hip fracture.Patient was implanted with a tfn proximal femoral nailing system (tfn); 170 mm titanium cannulated trochanteric fixation nail, 11.0 mm helical blade and a locking screw.On (b)(6) 2017, patient underwent revision surgery due to a fall in which she fractured her femur below the tfna.All hardware was removed intact and patient was converted to a long tfna with no delay in surgery.Patient outcome was reported as stable.This report is for one (1) ti cannulated troch fixation nail sterile.This is report 1 of 3 for com-(b)(4).

Manufacturer Narrative

Device history records review was requested and was unable to performed due to invalid lot number.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.

• Brand Name: 10MM/130 DEG TI CANN TROCH FIXATION NAIL 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6282545
• MDR Text Key: 65941529
• Report Number: 1719045-2017-10061
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011857
• 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: 01/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 456.315S
• Device Lot Number: 9843998
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2017
• 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
• Patient Outcome(s): Required Intervention