MAUDE Adverse Event Report: SYNTHES USA; NAIL, FIXATION, BONE

Device Problem Migration or Expulsion of Device (1395)

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

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: event date: unknown, unknown part number, unknown lot number, udi is unavailable.This report is for unknown nail/unknown lot number.Original trochanteric femoral nail (tfn) was implanted (b)(6) 2014.Device is not expected to be returned for manufacturer review/investigation.Original therapy/surgery date of implant was january 2014.The complaint indicated that the blade had migrated, which required additional surgical intervention.The 510k#: unknown.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.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 a patient underwent a revision surgery on (b)(6) 2016 due to a helical blade that perforated through the femoral head.It was reported the patient had a refracture of the area.The original trochanteric femoral nail (tfn) was implanted (b)(6) 2014 for a hip fracture.There was no surgical delay noted in the revision surgery.All devices were removed intact with no breakage or fragment generation.The patient was revised to a competitor's bipolar hip implant.The procedure was completed successfully.This complaint involves 1 device.Concomitant device: nail, unknown part, unknown lot, qty 1.Screw, unknown part, unknown lot, qty unknown.This report is 1 of 1 for (b)(4).

• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5906579
• MDR Text Key: 53092742
• Report Number: 2520274-2016-14364
• Device Sequence Number: 1
• Product Code: JDS
• 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: 08/10/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/10/2016
• Initial Date FDA Received: 08/26/2016
• 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
• Treatment: SCREW, UNKNOWN PART, UNKNOWN LOT, QTY UNKNOWN
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR