MAUDE Adverse Event Report: SYNTHES MONUMENT; ROD,FIXATION,INTRAMEDULLARY

Device Problem Unintended Movement (3026)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Patient weight not available for reporting.This report is for an unknown tfna nail-long.Device remains implanted and was not explanted complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.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 was reported that a tnfa (trochanteric fixation nail-advanced) nail failed postoperatively.It was further explained that the nail, unknown helical blade and distal locking screw (quantity unknown) were originally implanted on (b)(6) 2017 and post-operative x-rays taken on an unknown date during a postoperative visit revealed that the locking mechanism in the nail has failed to lock causing the helical blade to migrate or slide out of its intended position.Reportedly, nail was locked per procedure using a torque limiting guide and x-rays taken right after the surgery showed the construct locked in the proper location and that the locking mechanism in the nail appeared to be down.The patient is reported to be in pain but "ok" and there are currently no plans to revise the construct at this time.Should the patient be revised at a later date, the construct will be returned for investigation.Concomitant devices reported: distal locking screws.This report is for one (1) unknown tfna nail long.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

A physical device was not returned but x-rays were reviewed.The complaint of migration was able to be confirmed via the x-rays but the complaint of the locking mechanism failing could not be confirmed.Pre/intra-operative x-rays shows the lateral side of the helical blade within the lateral cortex of the bone but postoperative x-rays show the blade extending past the lateral cortex.A drawing review could not be performed as the physical product was not returned for evaluation.Replication of the complaint is not applicable as the malfunction occurred in situ and the part was not returned for investigation.A definitive root cause could not be determined as the circumstances around the malfunction are unknown or cannot be confirmed.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.

• 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: 6981950
• MDR Text Key: 90388747
• Report Number: 1719045-2017-11118
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR