MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW ROD TI 5.5X300

Catalog Number	03.50.402
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 october 2018.Lot 1620466: (b)(4) items manufactured and released on 02 june 2017.Expiration date: 2022-04-17.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.Visual inspection performed by washing and packaging manger on oct 25, 2018: it can be confirmed that the packaging is compromised, the rod perforated the peel pouch, probably during transportation or storage.Considering the rod design and length, 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.The packaging configuration 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.
Event or Problem Description
The rod inner plastic packaging was found broken during surgery.A back-up implant, rod packed with protective endcaps, was used to complete the surgery.

• Brand Name: PEDICLE SCREW ROD TI 5.5X300
• Common Device Name: ROD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8004632
• Report Number: 3005180920-2018-00824
• Device Sequence Number: 13799659
• Product Code: KWP
• UDI-Device Identifier: 07630030835353
• UDI-Public: 07630030835353
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/25/2018

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: 04/17/2022
• Device Catalogue Number: 03.50.402
• Device Lot Number: 1620466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2018
• Initial Report FDA Received Date: 10/25/2018
• 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