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

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Patient weight is unknown.Event date: unknown.This report is for an unknown 6.5mm recon screw/unknown lot.Part and lot number are unknown; udi number is unknown.Implant date: unknown.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 patient was implanted with a 300mm titanium cannulated lateral entry femoral recon nail, a 6.5mm recon screw, and four (4) titanium stardrive locking screws on an unknown date to repair a femur fracture.On an unknown date, the patient reported feeling some pain after a fall.Upon evaluation, it was discovered that the fixation was collapsed and had failed.It was clarified that upon examination, it was noted that the complained devices had migrated.On (b)(6) 2016, the patient was returned to the operating room for a revision surgery to remove the complained devices.All of the devices were removed and found to be intact.The procedure was completed successfully with no reports of delay or medical intervention.This report is for an unknown 6.5mm recon screw.This is report 2 of 3 for (b)(4).

• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6095564
• MDR Text Key: 59718773
• Report Number: 2520274-2016-15351
• 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
• Report Date: 10/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2016
• 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: 10/15/2016
• 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: 40 YR