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

Catalog Number	02.09.TA310
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch reviews performed on 19 july 2017.Lot 123245a: (b)(4) items manufactured and released on 16 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 femoral wedge posterior size 3/10mm, code 02.07.310fpw, lot.135785 (k102437) (b)(4) items manufactured and released on 28 april 2014.Expiration date: 2018-12-31.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 19july 2017 the cleaning and packaging manager performed a preliminary investigation based on the available pictures and commented as follows: - wedge: as visible in the attached picture the packaging is damaged.The nature of the damage presents, as visually evident, allowing the surgeon to use another femoral wedge.The inner pouch of this packaging configuration was not sufficient to withstand the anomalous shipping stresses experienced in combination with the weight and geometry of the device.- tibial augmentation: as visible in the attached picture the primary sterility packaging 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.
Event or Problem Description
When the tibial augment was opened, it was noticed that the internal packaging was punctured.The surgeon believed the sterility was not compromised so he decided to implant the subject tibial augment.Also, the packaging of the posterior femoral wedge found was found torn.The surgeon did not implant the subject posterior femoral wedge as he thought the sterility may be compromised.The surgeon proceeded using a second implant (different size) to complete the case.The surgery was completed successfully.

• Brand Name: GMK-REVISION 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: 6724704
• Report Number: 3005180920-2017-00390
• Device Sequence Number: 652990
• Product Code: KRO
• UDI-Device Identifier: 07630030825705
• UDI-Public: 07630030825705
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 07/19/2017

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: 05/31/2019
• Device Catalogue Number: 02.09.TA310
• Device Lot Number: 123245A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2017
• Initial Report FDA Received Date: 07/19/2017
• 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
• Patient Age: 65 YR