MAUDE Adverse Event Report: SYNTHES MONUMENT 11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 456.318S

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/26/2017

Event Type  malfunction  

Manufacturer Narrative

Patient weight not available for reporting.Additional product code: hwc udi: (b)(4).Device was not explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.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 was reported that on (b)(6) 2017 the patient underwent an open reduction internal fixation (orif) of the femur to treat a fracture.The patient was implanted with devices from both the trochanteric fixation nail advanced (tfna) system and the trochanteric fixation nail (tfn) system using tfna instrumentation.The patient was implanted with a tfn nail and a tfna helical blade.Upon insertion, the helical blade was removed and a shorter 95mm helical blade was implanted.The surgeon had difficulty advancing the set screw although eventually it was advanced.The connection between the insertion handle and the tfna nail was reported as not being a good fit although the instrument was used for its intended purpose.The tfna nail was locked distally although some difficulty was reported.There was a five (5) minute delay due to switching the larger helical blade for a smaller device.No harm was reported to the patient.The procedure was successfully completed.Post-operatively it was confirmed the patient was implanted with a prior generation tfn nail with a tfna helical blade.The off-label use was then discussed with the surgeon.This report is for one (1) trochanteric fixation nail.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

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

Upon insertion, the helical blade was removed and a shorter 95mm helical blade was implanted [at the surgeon's discretion].The connection between the insertion handle and the tfn nail was reported as not being a good fit although the instrument was used for its intended purpose.The tfn nail was locked distally although some difficulty was reported.

• Brand Name: 11MM/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: 6519248
• MDR Text Key: 73739302
• Report Number: 1719045-2017-10345
• 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: 03/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 456.318S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/30/2017
• Initial Date FDA Received: 04/25/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/24/2017
• 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 Age: 76 YR