MAUDE Adverse Event Report: SYNTHES MONUMENT TFNA HELICAL BLADE 90MM STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.038.290S

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Patient identifier and weight not available for reporting.Date of device cut out is not known.(b)(4).Device was not explanted complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Dhr review was completed.Part #: 04.038.290s, lot#: h167798 (sterile) - tfna helical blade 90 mm -sterile, quantity 48.Raw material part no: 21012 lot number 9974142 reviewed.Raw material receiving/putaway checklist meet requirements.Inspection sheet and in-process acceptance sheet meet specification.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.¿sterility documentation was reviewed and determined to be conforming.¿ ¿sterility documentation was reviewed and determined to be conforming.¿ manufacturing location: (b)(4), manufacturing date: 08-sep-2016, expiration date: 01-aug-2026, 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

Device report from synthes europe reports an event in (b)(6) as follows: it was reported patient was implanted with the trochanteric femoral nail advanced (tfna) system on (b)(6) 2017 for a femoral trochanteric fracture.The tfna helical blade was inserted above the center position (tip of the blade directed superior).Surgeon also confirmed placement at the time of surgery.On (b)(6) 2017, it was noted the proximal femoral head rotated and the tip of the blade almost penetrated the femoral head.Surgeon suspects a bipolar hip arthroplasty may be needed in the future but has not yet been scheduled.Patient is currently being monitored medically.Concomitant devices reported: tfna nail (04.037.942s, lot h050793, quantity 1), 5.0 mm locking screw (04.005.520s, lot 9531652, quantity 1).This report is for one (1) tfna helical blade.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

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.

Manufacturer Narrative

Device was used for treatment, not diagnosis.A customer quality (cq) evaluation was performed for the subject device.Product was not returned.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Based on x-ray review the complained issue of (proximal femoral head bone rotated and the tip of the blade almost penetrated the femoral head (but not penetrated yet), could be confirmed.No indication for product related issue was found.Medical safety: x-ray review: the placement of the helical blade (hb) is adequate and tad appears to be < 25 mm.However, the initial reduction is distracted.Over time the tfna performs perfectly sliding laterally.However, the hb may have reached its lateral slide limit before the fracture reached a point of stability or significant contact.At this point the head-neck will continue to migrate laterally seeking necessary bony stability, however all ¿sliding¿ at this point will occur with the femoral head moving laterally on the hb.Report was initially submitted on october 27, 2017 but the fda site was down.Advised by fda on november 06, 2017 to resubmit medwatch.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TFNA HELICAL BLADE 90MM 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: 6887278
• MDR Text Key: 87203927
• Report Number: 1719045-2017-10965
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.290S
• Device Lot Number: H167798
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR