MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION OFFSET CONNECTOR 5 MM

Catalog Number	02.07.0005
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2018: lot 172194: 100 items manufactured and released on 21 september 2017; expiration date: (b)(6) 2022.No anomalies found related to the event.To date, 50 items of the same lot have been already sold without any similar reported issue.Preliminary investigation performed by washing and packaging manager on (b)(6) 2018 the displacement likely occurred due to forces experienced during transportation.This is indicated to correlate to the combination of the packaging configuration applied and the short length of the offset connector as they allow more degrees of freedom for movement within the package.
Event or Problem Description
When getting the appropriate implants for the surgeon the sales agent noticed that the inner bag of the implant was compromised.The agent had a secondary implant, same lot, to cover the case.
Additional Manufacturer Narrative
Visual inspection performed on 28 march 2018 by packaging and washing manager: the event and the preliminary analysis are confirmed: the displacement likely occurred due to forces experienced during transportation.This is indicated to correlate to the combination of the packaging configuration applied and the short length of the offset connector as they allow more degrees of freedom for movement within the package.

• Brand Name: GMK-REVISION OFFSET CONNECTOR 5 MM
• Common Device Name: OFFSET CONNECTOR
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7345472
• Report Number: 3005180920-2018-00162
• Device Sequence Number: 1054946
• Product Code: JWH
• UDI-Device Identifier: 07630030815607
• UDI-Public: 07630030815607
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K102437
• 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): 04/27/2018

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: 08/28/2022
• Device Catalogue Number: 02.07.0005
• Device Lot Number: 172194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/14/2018
• Supplement Date Received by Manufacturer: 02/14/2018
• Initial Report FDA Received Date: 03/16/2018
• Supplement Report FDA Received Date: 04/27/2018
• 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