MAUDE Adverse Event Report: SYNTHES SALZBURG 9MM TI SOLID FEMORAL NAIL 400MM; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 464.400

Device Problem Bent (1059)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: event date: unknown.Implant date is (b)(6) 2016, exact date is unknown.Explant date: unknown.Device is not expected to be returned for manufacturer review/investigation.(b)(6).Device was reported bent and the patient had a nonunion which lead to a revision.A device history record (dhr) review was performed on part # 464.400, lot # 5921831: manufacturing location: (b)(4), manufacturing date: 01.Mar.2013.No non conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A 100% inspection of the pending is performed and documented in inspection sheet at operation "(b)(6)." 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

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that the femoral nail was bent postoperatively.Original implant date is in (b)(6) 2016, exact date is unknown.There was a non-union due to the bent nail.The explant surgery was performed on an unknown date.Revision surgery was completed successfully.No other medical intervention needed.There was no patient harm.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

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.

• Brand Name: 9MM TI SOLID FEMORAL NAIL 400MM
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES SALZBURG; karolingerstrasse; salzburg 5020 ; AU 5020
• Manufacturer (Section G): SYNTHES SALZBURG; karolingerstrasse; salzburg 5020 ; AU 5020
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6439118
• MDR Text Key: 71012716
• Report Number: 3009417901-2017-10008
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K923580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 464.400
• Device Lot Number: 5921831
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention