MAUDE Adverse Event Report: SYNTHES MONUMENT 12MM/130 DEG TI CANN TROCH FIXATION NAIL 235MM-STERILE ROD, FIXATION, INTRAMEDULLARY

Catalog Number 456.511S

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 10/30/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis. (b)(4). Device remains implanted in the patient. Device is unavailable for return. (b)(4). A review of the device history records has been completed. Manufacturing location: (b)(4). Manufacturing date: april, 01, 2016 expiration date: february 28, 2025 part #: 456. 511s, lot#: h060893 (sterile) - 12mm/130 deg ti cann troch fixation nail 235mm-sterile. Quantity 6. No ncrs 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. Scn no: 12367, ¿sterility documentation was reviewed and determined to be conforming. ¿ 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. Device is not expected to return.

Event Description

It was reported that the internal screw that is pre-loaded in the trochanteric fixation nail (tfn) that locks down the lag screw was out of position and needed to be adjusted. The surgery was successfully completed with no harm to the patient. No surgical delay was reported. Concomitant device reported: lag screw (part # unknown, lot # unknown, quantity 1). This is report 1 of 1 for (b)(4).

• Brand Name: 12MM/130 DEG TI CANN TROCH FIXATION NAIL 235MM-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: 6129884
• MDR Text Key: 60990634
• Report Number: 1719045-2016-10856
• 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

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

1 Device was Involved in the Event

0 Patients were Involved in the Event:

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

Device Operator

• Device Catalogue Number: 456.511S
• Device Lot Number: H060893
• 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: 04/01/2016
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown