MAUDE Adverse Event Report: MEDACTA INTERNATIONAL, SA GMK HINGE TIBIAL AUGMENTATION SIZE 4, 10 MM

Device Problem Incorrect Device Or Component Shipped (2962)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

(b)(4).

Manufacturer Narrative

The batch was checked on 16 april 2015 after the notification of the problem to the headquarter.It was immediately detected that a wrong step during the packaging procedure was made by the operator and that the entire lot was packaged with screws of 5 mm instead of 10 mm.For this reason, a recall of the lot from the market has been initiated and reported to the fda.On 12 may 2015 the packaging dept mgr checked the retrieved item with the following comments: it is confirmed the presence of 5 mm screws instead of 10 mm.As reported in the investigation made into the capa opened, the event is due to a mistake of the operator that on 28 august 2014 wrongly picked 32 screws of 5 mm instead of the 10 mm.Other to have having picked the wrong code of screws, he ignored the system that checked the right codes of the picked items, forcing it manually.It is highly likely that the mistake was due to the fact that in the same days the same operator used the 5 mm screws to package other augments.

Manufacturer Narrative

"on (b)(6) 2015, it was prepared a final report with the information collected during the investigation, already reported in the initial report.On the same date the report was sent to the initial reporter and the case was closed.".

• Brand Name: GMK HINGE TIBIAL AUGMENTATION SIZE 4, 10 MM
• Type of Device: TIBIAL AUGMENTATION
• Manufacturer (Section D): MEDACTA INTERNATIONAL, SA; strada regina 6874; castel san pietro ; SZ
• Manufacturer Contact: erin baumstark ; strada regina 6874; castel san pietro ; SZ ; 3128782381
• MDR Report Key: 4774879
• MDR Text Key: 5799879
• Report Number: 3005180920-2015-00087
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K130299
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Type of Report: Initial,Followup
• Report Date: 07/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/28/2015
• Date Report to Manufacturer: 07/28/2015
• Date Manufacturer Received: 04/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1