MAUDE Adverse Event Report: SYNTHES MONUMENT 12MM/130 DEG TI CANN TFNA 380MM/RIGHT-STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.037.258S

Device Problems Break (1069); Crack (1135)

Patient Problems Pain (1994); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.(b)(4).Device is not expected to be returned for manufacturer review/investigation.Concomitant device reported: tfna helical blade 100 mm sterile, part #-04.038.300s, lot #-h258574.Quantity (1).Device history records review was conducted.The report indicates that the: manufacturing location: (b)(4), manufacturing date: 03-feb-2017, expiration date: 31-dec-2026, part #: 04.037.258s/lot#: h285808 (sterile) - 2 mm/130 deg ti cann tfna 380 mm/right- sterile.Qty 6.Inspection sheet for in-process/inspect dimensional/final ns063060 rev: g and inspection sheet - tfna assembly inspection met inspection acceptance criteria.Component parts reviewed: 04.037.942.2 - lock prong 130 degree, tfna bp-55 lot ¿ l237859, 04.037.912.4 - wave spring, shim ended bp-55 lot ¿ h045958, 04.037.912.3 - tfna lock drive bp-58 lot ¿ h250095, raw material received from ati specialty materials.Certificate of test received for titanium from ati specialty materials meet specification.Raw material receiving/putaway checklist meet requirements.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.¿ 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 the patient had a tfn nail surgery for a femur fracture for the right leg on (b)(6) 2017.The femur had broken on (b)(6) 2017.The patient was implanted with a synthes titanium nail and lag screw.The surgery was completed successfully with no surgical delay and no patient harm.After experiencing pain since (b)(6) 2017, the patient had x-rays taken on (b)(6) 2017.On an office visit with a second surgeon on (b)(6) 2017, the patient was told that the x-rays revealed a crack in the titanium nail.The second surgeon said that he was hoping that the bone would fuse around the cracked device and then just heal on it¿s own.The second surgeon believed that the bone would grow around the devices that were implanted.The patient came back to see that same surgeon on (b)(6) 2017.An mri was taken which revealed that the lag screw broke into two pieces, and the titanium nail was cracked.The second surgeon then decided that a revision surgery was needed to remove the two devices and implant a new construct for the patient.The revision surgery is scheduled to take place on (b)(6) 2017.This complaint has 2 devices.Concomitant device reported: tfna helical blade 100 mm sterile, part #-04.038.300s, lot #-h258574.Quantity (1).This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Patient height reported as 5¿5¿.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

Revision surgery took place on (b)(6), 2017 and was considered successful by the surgeon.The surgeon observed that both the nail and the screw were broken in two pieces.Both pieces of the nail were removed and only one piece of the screw was removed.The other part of the screw was left in the patient.The surgeon does not see a need for a follow-up surgery.Ms.Roberts said that the surgeon told her that the bone was wiggling before the surgery because of the broken devices.With the implanting of the new tfna set, the bone was stabilized.The patient is currently at rehab and no longer feels pain.The removed devices will be kept by the patient, and will not be returned.

• Brand Name: 12MM/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: 6862907
• MDR Text Key: 86089865
• Report Number: 1719045-2017-10904
• 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: other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 08/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 04.037.258S
• Device Lot Number: H285808
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 61