MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED FLEX #2/14

Catalog Number	02.12.0214FL
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 27 may 2019: lot 186009: 89 items manufactured and released on 30-oct-2018.Expiration date: 2023-10-15.No anomalies found related to the problem.To date, 5 items of the same lot have been already sold without any similar reported event.Preliminary investigation performed by packaging manager.From the pictures received is visible a wrong sealing of the packaging.I can exclude an accidental damage of the packaging as the envelope is damaged perfectly at the opening point.
Event or Problem Description
During the packaging opening it was noticed that the bag containing the insert inside the blister was open.The surgeon decided to use a new implant to complete the surgery.The implant was in the hospital as consignment.
Additional Manufacturer Narrative
On november 21th 2019 we have received the stem and head involved in the complaint.Visual inspection performed by packaging and washer manager: as reported in the preliminary investigation, the bag has been sealed correctly, because the sealing lines are evident.I exclude an accidental opening of the bag because it is damaged exactly at the level of the opening area.We can hypothesize that the bag had been previously opened, possibly by a different or team.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED FLEX #2/14
• Common Device Name: TIBIAL INSERT FIXED FLEX
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8649826
• Report Number: 3005180920-2019-00413
• Device Sequence Number: 16785866
• Product Code: JWH
• UDI-Device Identifier: 07630030826214
• UDI-Public: 07630030826214
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K121416
• 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,Followup
• Report Date (Section B): 12/11/2019

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: 10/15/2023
• Device Catalogue Number: 02.12.0214FL
• Device Lot Number: 186009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 05/29/2019
• Supplement Report FDA Received Date: 12/11/2019
• 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