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

Catalog Number 04.037.142S

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 11/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).Device not reported as explanted.Complainant part is not expected to be returned for manufacturer review/investigation, as it is reportedly still in the patient.Manufacturing location: (b)(4).Manufacturing date: september 29, 2016.Expiration date: august 31, 2026.Sterility documentation was reviewed and determined to be conforming.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.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 during the original trochanteric fixation nail-advanced (tfna) procedure performed on (b)(6) 2016 the locking mechanism inside the nail would not drop down the nail and thus could not lock the helical blade.The surgery was performed to treat intertrochanteric fracture.The surgeon decided to leave the implants implanted as it is.The surgery was successfully completed with no patient harm, additional medical intervention, or surgical delay.Patient status/outcome post-surgery reported as fine.Concomitant device reported as: tfna helical blade 90mm sterile (part 04.038.290s, lot h174773, quantity 1).This is report 1 of 1 for (b)(4).

• Brand Name: 11MM/130 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6173836
• MDR Text Key: 62460118
• Report Number: 1719045-2016-10911
• 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: 11/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.142S
• Device Lot Number: H194662
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 1 PART 04.038.290S, LOT H174773,TFNA HELICAL BLADE
• Patient Age: 95 YR