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

Catalog Number	02.09.TA505
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 148090: (b)(4) items manufactured and released on 09 march 2015.Expiration date: 2020-01-31 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 (2 pieces involved in this case) others devices involved: gmk-hinge femoral wedge posterior size 5/5 mm reference 02.05.05pw (k102437).Lot 156184: (b)(4) items manufactured and released on 18 march 2016.Expiration date: 2020-11-24 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-hinge offset connector 3 mm reference 02.07.0003 (k102437).Lot 174952: (b)(4) items manufactured and released on 22 november 2017 expiration date: 2022-11-01 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 inspection performed by washing and packaging manager on 31 august 2018.Tibial augmentation:as visible in the pictures 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.Femoral wedges: the implant was received and the packaging was confirmed to be broken, as it could be seen also from the picture provided at the moment of the notification.The inner pouch of the packaging configuration applied was not sufficient to withstand the anomalous shipping stresses experienced in combination with the weight and geometry of the device.A new packaging configuration for the femoral wedge product family has been developed and an updated validation master plan has been implemented in order to help prevent similar occurrences in the future.Offset connector:the involved implant was not received, but one picture was provided and the inner packaging breakage was confirmed.The displacement likely occurred due to forces experienced during transportation.This is indicated to correlate to the combination of the packaging configuration applied and the short length of the offset connector as they allow more degrees of freedom for movement within the package.A new packaging is underevaluation.
Event or Problem Description
During surgery it was noticed that several implants had packing damage.The surgeon had to use secondary implants to complete the case.

• Brand Name: GMK-HINGE TIBIAL AUGMENTATION SIZE 5/5MM
• Common Device Name: TIBIAL AUGMENTATION
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7837113
• Report Number: 3005180920-2018-00649
• Device Sequence Number: 1293755
• Product Code: KRO
• UDI-Device Identifier: 07630030825736
• UDI-Public: 07630030825736
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/31/2018

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: 01/31/2020
• Device Catalogue Number: 02.09.TA505
• Device Lot Number: 148090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 08/31/2018
• 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
• Patient Age: 70 YR