MAUDE Adverse Event Report: SYNTHES MONUMENT TFNA FENESTRATED SCREW 105MM - STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.038.205S

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Date of event: date of device migration is not known.Additional product code: ktt.(b)(4).Date of implant/explant is not known.Complainant part is not expected to be returned for manufacturer review/investigation.Concomitant device therapy date is not known.(b)(6).Dhr review was completed.Manufacturing location: (b)(6).Manufacturing date: 16-jan-2015.Expiration date: 31-jan-2025.Part #: 04.038.205s, lot#: 7876483 (sterile) ¿ 10.5mm ti tfna fenestrated screw 105mm -sterile, quantity (b)(4).Raw material part no: 21012 lot number 7704533 reviewed.Raw material receiving/putaway checklist meet requirements.Inspection sheet meet specification.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.¿sterility documentation was reviewed and determined to be conforming.¿ 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 patient was implanted with a 12mm 130 degree cannulated trochanteric femoral nail advanced (tfna) left and tfna fenestrated screw on unknown date.On unknown date it was determined the tfna fenestrated screw had migrated and was close to cut out.It had not pushed through the cortical bone of the femoral head but surgeon was concerned that it would.Patient was returned to surgery on an unknown date and revised to a total hip replacement.No obvious damage to the nail or screw was noted.Concomitant devices reported: 12mm 130 degree cannulated tfna nail-left (04.037.257s, lot 9874894, quantity 1).This report is for one (1) tfna fenestrated screw 105mm.This is report 1 of 1 for (b)(4).

• Brand Name: TFNA FENESTRATED SCREW 105MM - STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7004636
• MDR Text Key: 91199633
• Report Number: 1719045-2017-11155
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.205S
• Device Lot Number: 7876463
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention