MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MUST TI ROD 5.5 L 200; PEDICLE SCREW SYSTEM - ROD

Catalog Number	03.50.401
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 22 december 2017: lot 148171: (b)(4) items manufactured and released on 26 september 2016; expiration date: 2021-09-11.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Visual inspection performed by packaging department responsible on 22 dec 2017: the primary envelop (the one declared "not welded") has the part in opa/pe shorter than the standard.This envelop results to be somehow "worked" close to the welding and this leads to think that the welding was present when the packaging activity was performed.Furthermore, the secondary envelop (declared to be conforming) has the same defect, even if less evident, but in this case the part in opa/pe results to be sealed to the medical paper.We also checked, following aql 1.0 parameters, the envelops still in stock without any detection of non conformities.
Event or Problem Description
During the packaging opening the nurse noticed that one of the plastic bag welding was missing.The surgery was completed successfully using another rod.

• Brand Name: MUST TI ROD 5.5 L 200
• Common Device Name: PEDICLE SCREW SYSTEM - ROD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7142936
• Report Number: 3005180920-2017-00769
• Device Sequence Number: 11049012
• Product Code: KWP
• UDI-Device Identifier: 07630030835346
• UDI-Public: 07630030835346
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 12/22/2017

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: 09/11/2021
• Device Catalogue Number: 03.50.401
• Device Lot Number: 148171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2017
• Initial Report FDA Received Date: 12/22/2017
• 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: 62 YR
• Patient Weight: 82