MAUDE Adverse Event Report: SYNTHES MONUMENT 10MM/130 DEG TI CANN TFNA 440MM/RIGHT - STERILE; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.037.064S

Device Problem Break (1069)

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

Event Type  Injury  

Manufacturer Narrative

(b)(4).Exact date of original implant is unknown.Implant procedure was seven (7) months prior to revision on (b)(6) 2016.(b)(4).Device history records review was completed for part # 04.037.064s, lot # 7984367.Manufacturing location: (b)(4), manufacturing date: apr 24, 2015, expiration date: mar 31, 2025.No non conformance reports were generated during production.Review of the device history records 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 device was received and the product evaluation is in progress.No conclusion can be drawn.Device 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 a patient underwent a revision procedure on (b)(6) 2016 due to a broken trochanteric fixation nail advanced (tfna) and a fracture that had not healed completely.The original procedure to repair a right femur fracture was performed on an unknown date seven (7) months prior to the revision.The broken nail and incomplete healing was discovered via computerized tomography (ct) on an unknown date.During the revision, the broken tfna and an intact lag screw were removed.The patient was revised to a trochanteric fixation nail (tfn) construct.There was a reported surgical delay of less than ten minutes related to the removal of the distal portion of the broken nail.No additional medical intervention or additional x-rays were required.No fragments were left behind.The procedure was completed successfully with the patient in stable condition.Concomitant medical products: 105mm tfna lag screw (part #04.038.105s, lot #9820725, quantity 1).This report is for one (1) 10mm/130 deg ti cann tfna 440mm/right - sterile.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

During the revision surgery the broken trochanteric fixation nail advanced (tfna) and an intact lag screw were removed.The returned nail is broken at the proximal locking hole.There is a hole which was created in the nail approximately 16mm distal to the proximal locking hole along with heavy scratches around the area.This most likely occurred during the removal of the broken nail.The threads for the head element are damaged.The device shows some other minor surface wear.The returned concomitant lag screw shows significant surface wear and some deformation.This was likely caused by the broken nail as well as the explantation process.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.Sterility documentation was reviewed and determined to be conforming.A visual inspection, complaint history review, drawing review, dhr review and risk assessment review were performed as part of this investigation.The complaint is confirmed.Device was used for treatment, no diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 10MM/130 DEG TI CANN TFNA 440MM/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: 6103674
• MDR Text Key: 59965749
• Report Number: 1719045-2016-10830
• 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: 10/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 04.037.064S
• Device Lot Number: 7984367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: PART #04.038.105S, LOT #9820725, QUANTITY 1
• Patient Outcome(s): Required Intervention