MAUDE Adverse Event Report: SYNTHES MONUMENT 11.0MM TI TROCH FIXATION NAIL SCREW/95MM - STERILE; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.032.095S

Device Problem Difficult to Advance (2920)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/06/2016

Event Type  malfunction  

Manufacturer Narrative

Patient weight is unknown.Additional product code: hwc.Udi: (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.Manufacturing location: (b)(4).Manufacturing date: april 24, 2014.Expiration date: march 31, 2024.No non-conformance reports 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 event as per complaint description cannot be associated with the sterility process of the product.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 the patient was implanted with a trochanteric fixation nail (tfn), locking screw, and lag screw on (b)(6) 2016.During the initial procedure, the surgeon stated he was unable to advance the lag screw all the way.The patient was returned to surgery on (b)(6) 2016 due to a superior cut out of the femoral head by the lag screw.Explant surgeon removed the nail, locking screw, and lag screw.The patient was revised to a dynamic hip screw (dhs).Surgery was completed successfully with no delay and no harm to patient.The issue reported with the advancement of the lag screw during the initial procedure is addressed in this complaint.The revision of the construct is addressed in linked complaint (b)(4).Concomitant devices reported: trochanteric fixation nail (part 456.318, lot 7950351, quantity 1); locking screw (part and lot number unknown, quantity 1) this is report 1 of 1 for (b)(4).

• Brand Name: 11.0MM TI TROCH FIXATION NAIL SCREW/95MM - 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: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5851604
• MDR Text Key: 51344849
• Report Number: 1719045-2016-10577
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092646
• 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: 07/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 04.032.095S
• Device Lot Number: 7654501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 77 YR