MAUDE Adverse Event Report: SYNTHES MONUMENT TFNA SCREW 95MM - STERILE; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.038.095S

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

Patient Problems Pain (1994); Impaired Healing (2378); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).(b)(4).Manufacturing location: (b)(4).Manufacturing date: may 04, 2016.Expiration date: march 31, 2026.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.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.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 is reported the patient was implanted with a non-synthes inflatable femoral nail on unknown date for a left midshaft femoral fracture with a large medial butterfly fragment.On unknown date, it was determined that the implant was bent.The patient was returned to surgery on (b)(6) 2016 where all hardware was removed.The patient was then revised to the 11mm long nail trochanteric femoral nail advanced (tfna), a 95mm lag screw, and two (2) 5.0mm distal locking screws.During routine follow up examination, the patient reported pain in the left femur.X-rays take that day showed nearly complete healing of the medial butterfly fragment.However, the lateral cortex failed to unite, causing a varus deformity at the knee.The patient was again returned to surgery on (b)(6) 2016 where all hardware was again removed.The patient was revised to a 12mm nail, another 95mm lag screw, one (1) 5.0mm distal locking screw, and two (2) distal blocking screws to correct the deformity.The surgery was completed successfully with no delay and no harm to patient.This is report 2 of 4 for (b)(4).

• Brand Name: TFNA SCREW 95MM - 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: 6155793
• MDR Text Key: 61852242
• Report Number: 1719045-2016-10895
• 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: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.095S
• Device Lot Number: H090566
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention