MAUDE Adverse Event Report: SYNTHES MEZZOVICO 5.0MM TI LOCKING SCR SLF-TPNG WITH T25 STARDRIVE RECESS 75MM; APPLIANCE,FIXATION,NAIL

Catalog Number 412.224

Device Problems Partial Blockage (1065); Break (1069); Fitting Problem (2183)

Patient Problem Failure of Implant (1924)

Event Date 09/05/2014

Event Type  Injury  

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that this was the second revision of the surgery.This patient originally had a periprosthetic fracture on an unknown date in (b)(6) 2013.The first revision surgery was non synthes plate, after the implant failure the patient was treated for a second revision.A refresh of the two bone ends and resection of both sides on the bone was done and a little valgus position was left.The second revision was completed with a non synthes plates on the ventral side and a dynamic compression plate with a less invasive stabilization system for distal femur.A synthetic bone graft was also used.The plate broke on an unknown date in (b)(6) 2014.It was also reported that per an internal review by the medical director; a periprosthetic fracture was determine by the x-ray images.Per additional information received; there was plate broken and there was is a screw that is stuck in the plate.This report is 3 of 3 for complaint (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.The investigation could not be completed; no conclusion could be drawn, as the product is entering the complaint system.A review of the device history records was performed and no complaint related issues were found.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional narrative: original implant was on an unknown date in (b)(6) 2013.Manufacturing evaluation: our investigation has shown that one blocked locking compression plate locking screw is in the plate.Unfortunately, as no detailed clinical information is available, we are not able to determine the cause which has led to this circumstance.It is likely that there was a complication during operation/removal or the healing process that caused this problem.Event date: unknown.Device 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: 5.0MM TI LOCKING SCR SLF-TPNG WITH T25 STARDRIVE RECESS 75MM
• Type of Device: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH68 05; SZ CH6805
• Manufacturer (Section G): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH68 05; SZ CH6805
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4144060
• MDR Text Key: 4915543
• Report Number: 1000562954-2014-10189
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK000682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 412.224
• Device Lot Number: 8606658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR
• Patient Weight: 65