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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Type  Injury  

Manufacturer Narrative

Date of postoperative device migration is unknown; however, the onset of additional pain occurred during (b)(6) 2016.This report is for one (1) unknown pfna blade.Additional product codes for this report include hwc.The complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).Device is not distributed in the united states, but is similar to a device marketed in the us.Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.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

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that a patient underwent a revision procedure on (b)(6) 2016 due to a migrated blade that cut through the acetabulum.The patient was originally treated for a peritrochanteric fracture of the right hip with the implantation of a proximal femoral nail antirotation (pfna) construct on (b)(6) 2012.During a routine radiographic follow up on (b)(6) 2013, it was noted that the fracture had compressed and the blade slid back as intended to allow for the compression.By (b)(6) 2016, however, the patient began reporting the onset of new hip pain and an inability to walk.It was discovered via x-ray (on an unknown date) that the blade had migrated and cut through the acetabulum, penetrating the hip joint.As a result, the patient returned to the operating room to have the original hardware removed.No additional information is available.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Added the concomitant devices (nail and screw) to the applicable field on the medwatch.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.

• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5537609
• MDR Text Key: 41528999
• Report Number: 2520274-2016-11887
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2016
• Initial Date FDA Received: 03/31/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/31/2016
• 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: 67 YR
• Patient Weight: 95