MAUDE Adverse Event Report: SYNTHES MONUMENT 11MM/130 DEG TI CANN TFNA 380MM/RIGHT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.037.158S

Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.(b)(4).Original implant date unknown maybe in 2016 or (b)(6) 2017.Device is not expected to be returned for manufacturer review/investigation.Device history records review was conducted.The report indicates that the: manufacturing location: (b)(6); manufacturing date: 24-jun-2016; expiration date: 31-may-2026.Part #: 04.037.158s, lot#: h130167 (sterile)11mm/130 deg ti cann tfna 380mm/right- sterile.Quantity 6.Inspection sheet for in-process/inspect dimensional/final ns063045 rev: e and inspection sheet - tfna assembly inspection ns067861 rev: a met inspection acceptance criteria.Component parts reviewed: 04.037.942.2 - lock prong 130 degree, tfna bp-55 lot - 9951107; 04.037.912.4 - wave spring, shim ended bp-55 lot - h045933; 04.037.912.3 - tfna lock drive bp-58 lot - h083621; 21127 - raw material lot bp-80 lot - h048989.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.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 a patient underwent the removal of a trochanteric femoral nail advanced (tfna) nail and lag screw and was revised to a depuy total hip on (b)(6) 2017.The patient had initially been implanted with the tfna nail and lag screw in either (b)(6) 2016 or (b)(6) 2017 and had fallen on an unknown date.An x-ray, date unknown, revealed that the fracture was in the femoral head and that the nail had pulled out of place.It was reported that both devices were intact and easily removed.The surgery was completed successfully, without delay, and the patient reported as stable.This complaint is for two devices.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

(b)(6).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

Clarification was received that it was the lag screw that had pulled out of place not the nail as previously reported.

• Brand Name: 11MM/130 DEG TI CANN TFNA 380MM/RIGHT - 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: 6440678
• MDR Text Key: 71093766
• Report Number: 1719045-2017-10262
• 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,Followup
• Report Date: 03/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.158S
• Device Lot Number: H130167
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 93 YR
• Patient Weight: 58