MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 2/23MM

Catalog Number 02.09.0223H

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/16/2017

Event Type  malfunction  

Manufacturer Narrative

Batch review performed on 17 may 2017.Lot 163646: (b)(4) items manufactured and released on 30 june 2016.Expiration date: 2021-06-09.No anomalies found related to the problem.To date, no other items of the same lot have been already sold.All pieces of this lot have been recall from the market.On 14 june 2017 the cleaning and packaging manager performed a visual inspection of the retrieved items (the second opened liner plus the post fixation screw, and the wrong post fixation screw found in the first opened liner), and commented as follows: the hinge inlay locking screw was missing.There were two (2) hinge post fixation screws, while the requirement is to have 1 inlay locking screw and 1 post fixation screw.The primary root cause is the lack of visually evidence and distinguishing identification of very similar, but different parts, being applied within the same final packaging assembly.Additionally, a lack of an additional subsequent verification step contributed to the lack of detection.Corrective actions have been implemented in order to avoid similar cases in the future.The liner was implanted.

Event Description

The hinge inlay locking screw was missing.Two hinge post fixation screws were found in the packaging.A second insert had to be used in order to have the correct locking screw.The surgery was thus completed with the first liner and the locking screw of the second liner.

• Brand Name: GMK-HINGE FIXED TIBIAL INSERT SIZE 2/23MM
• Type of Device: FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6640056
• MDR Text Key: 77727989
• Report Number: 3005180920-2017-00304
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K130299
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2021
• Device Catalogue Number: 02.09.0223H
• Device Lot Number: 163646
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/30/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 98