MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M.U.S.T. ROD TI 5.5X480; SPINAL ROD

Catalog Number	03.50.403
Medical Device Problem Code	Device Packaging Compromised (2916)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 27 september 2017 the cleaning and packaging manager performed a visual inspection of the retrieved packaging and commented as follows: it could be confirmed that the packaging was compromised, the rod perforated the peel pouch probably during transportation or storage.Considering the rod design and length, if it is not carefully managed, it can be involved in packaging breakage.The most probable root cause is due to the interaction of the following factors: - the material of the pouch, opa/pe.- the folding of the pouch.- lot specific handling damage during packaging and/or sterilization.Specifically, it is possible that there was lot specific damage during the packaging production process and/or sterilization process, as the packaging configuration (opa/pe pouches and pouch folding) has been validated for shipping under normal operating conditions.A project has been opened to create a more resistant packaging configuration, inserting two plug at the rod extremities composed as follow: -1 in tpu on the rod tips; -1 mousse plug on the tpu plugs; furthermore the opa/pe pouches will be substituted with a more resistant polyethylene sachet.Batch review performed on 02 october 2017.(b)(4).
Event or Problem Description
The internal packaging was damaged, therefore the sterility of the product was compromised.The surgeon used other rods to complete the surgery successfully.

• Brand Name: M.U.S.T. ROD TI 5.5X480
• Common Device Name: SPINAL ROD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6913759
• Report Number: 3005180920-2017-00549
• Device Sequence Number: 1444448
• Product Code: KWP
• UDI-Device Identifier: 07630030835360
• UDI-Public: 07630030835360
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K121115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/04/2017

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: 07/11/2021
• Device Catalogue Number: 03.50.403
• Device Lot Number: 1520147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2017
• Initial Report FDA Received Date: 10/04/2017
• 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: 39 YR