MAUDE Adverse Event Report: SYNTHES MONUMENT 12MM/130 DEG TI CANN TROCH FIXATION NAIL 400MM/LEFT-STER; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 456.481S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional patient information: patient height reported as 5 feet 5 inches.(b)(6).Additional device product code: hwc.(b)(4).Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device history record review for part #: 456.481s, lot#: 7867789 (sterile) - 12mm/130 deg ti cann troch fixation nail 400mm/left - sterile.Quantity (b)(4): manufacturing location: (b)(4), manufacturing date: 19 dec 2014, expiration date: 30-nov-2023.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.Sterility documentation was reviewed and determined to be conforming.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 is reported patient was implanted with a 12mm x 400mm trochanteric fixation nail (tfn)-left, one (1) 90mm lag screw, and two (2) 5.0mm distal locking screws on (b)(6) 2015.On unknown date, patient reported pain.Patient was returned to surgery on (b)(6) 2016 where surgeon removed all hardware.All explanted hardware was intact.Surgery was completed successfully with no delay and no harm to patient.It is reported surgeon plans to wait a few weeks, then revise patient to a total hip implant.This is report 1 of 3 for (b)(4).

• Brand Name: 12MM/130 DEG TI CANN TROCH FIXATION NAIL 400MM/LEFT-STER
• 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6142836
• MDR Text Key: 61396602
• Report Number: 1719045-2016-10876
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011857
• 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: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 456.481S
• Device Lot Number: 7867789
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 75