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 Difficult to Remove (1528)

Patient Problem Sedation (2368)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Additional product code: hwc (b)(4).Part number: 456.481s, lot number: 7624064, raw material number: 7495723: manufacture date: 12 march 2014.Expiration date: 01 february 2023.A review of depuy synthes (b)(4) device history records for manufacturing revealed no issues.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 was reported a revision surgery took place on (b)(6) 2015.The original trochanteric fixation nail (tfn) system was being explanted because the helical blade had migrated into the joint of the hip.Original implant date is unknown.Patient was revised to a total hip implant.There was difficulty in explanting the nail.A surgical delay of one (1) hour was reported.Procedure was successfully completed with no patient harm.This is report 2 of 2 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5245549
• MDR Text Key: 31979650
• Report Number: 1719045-2015-10761
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK011857
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/05/2015

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
• Device Expiration Date: 02/01/2023
• Device Catalogue Number: 456.481S
• Device Lot Number: 7624064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2015
• Initial Date FDA Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention