MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW ROD COCR 5.5X200

Catalog Number	03.50.431
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 28 jun 2019: lot 144214: (b)(4) items manufactured and released on 05-sep-2016.Expiration date: 17-apr-2021.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with 1 other similar event reported, in total 4 items involved (2 in this complaint).Additional implant involved in this event: pedicle screw 03.50.432 rod cocr 5.5x300 (k121115) lot.144215.Batch review performed on 28 jun 2019: lot 144215: (b)(4) items manufactured and released on 03-jun-2015.Expiration date: 03-may-2020.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with 2 other similar events reported (4 items involved).Visual inspection performed by r&d project manager: in all the three rod packages the inner peel pouch is broken.A potential root cause of the event could be a shock during the delivery of the implant.
Event or Problem Description
Once the nurse opened the box of the implant (2 of 200 mm rods and 1 of 300 mm rod), the packaging of the rod (double "paper") was broken.Another rod (5.5x300) was opened and used but, in order to have the desired dimension, it was cut.

• Brand Name: PEDICLE SCREW ROD COCR 5.5X200
• Common Device Name: PEDICLE SCREW ROD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8802420
• Report Number: 3005180920-2019-00577
• Device Sequence Number: 16229055
• Product Code: KWP
• UDI-Device Identifier: 07630030835421
• UDI-Public: 07630030835421
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/18/2019

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: 04/17/2021
• Device Catalogue Number: 03.50.431
• Device Lot Number: 144214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 07/18/2019
• 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