MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE TIBIAL AUGMENTATION SIZE 3/10MM

Catalog Number	02.09.TA310
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 17 october 2017.Lot 123245: (b)(4) items manufactured and released on 30 january 2013.Expiration date: 2017-12-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.On 20 october 2017 the cleaning and packaging manager performed a visual inspection of the retrieved item and commented as follows: as visible in the attached picture and confirmed through the visual inspection of the retrieved item, the primary sterility packaging is damaged.It is likely that the handling activities caused agressive tibial component movement in the primary sterility packaging, causing the breakage of the primary barrier and impacting the secondary sterility blister.
Event or Problem Description
When the tibial augment was opened, it was noticed that the inner packaging was compromised.The surgeon used a secondary implant to complete the surgery.The surgery was completed successfully.

• Brand Name: GMK-HINGE TIBIAL AUGMENTATION SIZE 3/10MM
• Common Device Name: TIBIAL AUGMENTATION
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6965054
• Report Number: 3005180920-2017-00603
• Device Sequence Number: 11035590
• Product Code: KRO
• UDI-Device Identifier: 07630030825705
• UDI-Public: 07630030825705
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: 02.09.TA310
• Device Lot Number: 123245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 10/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other