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

Catalog Number	03.50.432
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 23-may-2018.Lot 144215: (b)(4) items manufactured and released on 03-june-2015.Expiration date: 2020-05-03 no anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with a similar reported event.On may 8, 2018 the washing and packaging manager performed a visual inspection of the retrieved packaging and commented as follows: 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, handling damage during packaging and/or sterilization.The packaging configuration has been validated for shipping under normal operating conditions.After the previous cases received, project was 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 was substituted with a more resistant polyethylene sachet.
Event or Problem Description
The packaging was broken with the tip of the rod out of the double pack.The external box was perfect.No delay due to this issue; a backup implant was available.
Additional Manufacturer Narrative
On 27 july 2018 other 3 packaging rods involved in the case were received.The visual inspection performed on 8 may 2018 is confirmed.

• Brand Name: PEDICLE SCREW ROD COCR 5.5X300
• Common Device Name: ROD COCR
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7540701
• Report Number: 3005180920-2018-00358
• Device Sequence Number: 11206514
• Product Code: KWP
• UDI-Device Identifier: 07630030835438
• UDI-Public: 07630030835438
• 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,Followup
• Report Date (Section B): 08/24/2018

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: 05/03/2020
• Device Catalogue Number: 03.50.432
• Device Lot Number: 144215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2018
• Supplement Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 05/24/2018
• Supplement Report FDA Received Date: 08/24/2018
• 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
• Patient Age: 37 YR