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

Device Problem Unintended Movement (3026)

Patient Problems Fall (1848); Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for one (1) unknown helical blade.Without the specific part and lot number, the udi is not available.Complainant device is not expected to be returned for manufacturer review/investigation.The (510k): unknown, as specific part and lot numbers for helical blade is not provided.(b)(4) used to capture additional medical/surgical intervention required.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 patient underwent a trochanteric fixation nail advanced (tfna) removal and conversion to a total hip prosthesis on (b)(6) 2017.The date of the original tfna procedure was (b)(6) 2017.Subsequently, the patient sustained a fall, and it was discovered that there was helical blade cut-out in the anterior portion of the femoral head.Removed hardware included the tfna construct: cephalomedullary nail, helical blade, and locking screw ¿all intact.A total hip prosthesis was then implanted.Nothing untoward occurred during this procedure.The procedure was completed successfully with the patient in stable condition.The surgeon stated that in his opinion, the original helical blade may have been placed too inferiorly and anteriorly, possibly contributing to the cut-out.Concomitant devices reported: 11 mm/130 degree ti cannulated tfna 235 mm/left - sterile (part #-04.037.145s; quantity 1), 5 mm locking screw (quantity 1).This report is for one (1) unknown helical blade.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Customer quality (cq) engineer reviewed the 2 provided x-rays and could not definitively confirm the complaint condition.There is not sufficient evidence based on the angles of the 2 provided x-rays to confirm the complaint condition from an engineering perspective.The angles of the provided x-rays were not sufficient to determine the location/position of the implants with respect to each other.Corrected data: patient weight reported as (b)(6).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 USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6846383
• MDR Text Key: 85087183
• Report Number: 2520274-2017-12218
• 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: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• 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: 10/13/2017
• 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 Weight: 49