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

Catalog Number 04.037.042S

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

Patient Problem Hip Fracture (2349)

Event Date 11/02/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis. (b)(4). Nail and construct was implanted on (b)(6) 2016, but remains successfully implanted in the patient. Device is unavailable for return. The investigation could not be completed; no conclusion could be drawn, as no product was received. A review of the device history records has been completed. Manufacturing location: (b)(4). Manufacturing date: march 30, 2016, expiration date: july 31, 2026. Part #: 04. 037. 042s, lot#: h177968 (sterile) - 10mm/130 deg ti cann tfna 170mm - sterile, quantity 6. No non-conformance records (ncrs) were generated during production. Review of the device history record(s) showed that there were no other issues during the manufacture of the product that would contribute to this complaint condition. Scn no: (b)(4) ¿sterility documentation was reviewed and determined to be conforming. " if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Device is not returning.

Event Description

It was reported that a patient was treated on (b)(6) 2016 for a left incomplete femoral neck intertrochanteric fracture (the fracture did not go all the way across the femoral neck) with the tfna (trochanteric femoral nail-advanced) system. As the tfn-a nail was being inserted, the femoral neck intertrochanteric fracture broke completely, and the two ends of the fracture displaced. The surgeon was able to align the fracture, and complete the reduction. The helical blade and distal locking screw were placed without complication. There was no surgical delay, no reported patient harm, and the procedure completed successfully. The surgeon took intraoperative x-rays to evaluate the fracture and the reduction. Based on the evaluation of the x-rays, no further surgical or medical intervention is indicated at this time. This report is for one (1) tfna nail this is report 1 of 1 for (b)(4).

• Brand Name: 10MM/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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6128671
• MDR Text Key: 60929568
• Report Number: 1719045-2016-10852
• 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

• Type of Report: Initial
• Report Date: 11/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 04.037.042S
• Device Lot Number: H177968
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/02/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/30/2016
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 11/28/2016 Patient Sequence Number: 1