MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE HINGE POST EXTENSION 20 MM -TINBN COATED; KNEE POST EXTENSION

Catalog Number	02.09.HE20
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review of the lots involved in the mix-up (not confirmed) performed on 28-aug-2024 gmk-hinge 02.09.He20 gmk-hinge hinge post extension 20 mm -tinbn coated lot 2300554: 10 items manufactured and released on 22-mar-2023.Expiration date: 2028-03-05.To date, 03 items of the same lot have been sold without any similar reported event during the period of review.One piece of the lot 2300554 was re-packed on december 1st 2023 gmk-revision 02.07.Scp17 tinbn coated sc peg - 17mm (k210010) lot 2306515: (b)(4) items manufactured and released on 03-may-2023.Expiration date: 2028-04-15.To date, 10 items of the same lot have been sold without any similar reported event during the period of review.One piece of the lot 2306515 was re-packed on december 1st 2023 analysis performed by washing and packaging manager: the two batches were packed in two completely different dates.The mix -up cannot be traced in the primary process: - lot 2300554 cleaning room packaging 07-mar-2023 - lot 2306515 cleaning room packaging 18-apr-2023 but on the 1st of december 2023 1 piece of the lot 2300554 and 1 piece of the lot 2306515 were repackaged.The scans of the repackages show that the reconciliation of the labels was performed correctly as per procedure.This does not exclude at all the error at this stage because maybe the operator have bipped the barcodes before phave packed the pieces and mixed-up them in the next step.The procedure also requires having only one batch on the workbench.The important point is that all available pieces of the lot 2306515, that were under medacta control, have been checked and no issue has been found so the mix-up was not confirmed.6 pieces checked and everything is okay, 3 already implanted, 1 was already discarded (due to different date of shipment and receipt cannot be the mixed ones).
Event or Problem Description
During the primary knee surgery, when the sales rep opened the peg for the poly insert (2306515), it was observed that a 20 mm post was in the implant box (2300554).The surgeon used a different size to complete the case.

• Brand Name: GMK-HINGE HINGE POST EXTENSION 20 MM -TINBN COATED
• Common Device Name: KNEE POST EXTENSION
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 20167518
• Report Number: 3005180920-2024-00725
• Device Sequence Number: 7040443
• Product Code: JWH
• UDI-Device Identifier: 07630971258525
• UDI-Public: 07630971258525
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K210010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

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 Catalogue Number: 02.09.HE20
• Device Lot Number: 2300554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown