MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION TIBIAL AUGMENTATION SIZE 5/10MM

Catalog Number	02.09.TA510
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 28 august 2018.Lot 123247a: (b)(4) items manufactured and released on 17 june 2014.Expiration date: 2019-05-31 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.Gmk-revision tibial augmentation size 4/10 mm reference 02.09.Ta410 (k130299) lot 155951: (b)(4) items manufactured and released on 30 november 2015.Expiration date: 2020-11-08.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.Visual inspection performed on aug 28, 2018 by packaging and washing manager: as visible in the picture initially provided and then confirmed through the visual inspection of the retrieved item, the primary sterility packaging of both the implants is damaged.It is likely that the handling activities caused aggressive tibial component movement in the primary sterility packaging, causing the breakage of the primary barrier and impacting the secondary sterility blister.A new packaging configuration has been developed and an updated validation master plan has been implemented in order to help prevent similar occurrences in the future.The involved lots were packed with the old packaging configuration.
Event or Problem Description
The nurse took the size 5 and the outer packaging was completely intact.He opened the foil of the inner packaging and found that the inner packaging was open.The same issue was found for the size 4.

• Brand Name: GMK-REVISION TIBIAL AUGMENTATION SIZE 5/10MM
• Common Device Name: TIBIAL AUGMENTATION
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7832919
• Report Number: 3005180920-2018-00639
• Device Sequence Number: 13770909
• Product Code: KRO
• UDI-Device Identifier: 07630030825743
• UDI-Public: 07630030825743
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/30/2018

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: 06/17/2014
• Device Catalogue Number: 02.09.TA510
• Device Lot Number: 123247A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 08/30/2018
• 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