MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA FLAT PE HC LINER Ø 32 / C; FLAT LINER

Catalog Number	01.26.3239HCT
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 23 april 2018.Lot 176069: (b)(4) items manufactured and released on 21 december 2017.Expiration date: 2022-12-03.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 on 12 april 2018 by washing and packaging manager: during the visual inspection also the pictures received from the branch were considered.Visually inspecting the inlay involved in the event we can confirm an unidentified black piece into the inlay internal cavity.The black dot, impurity, is very small and it is not possible to define its origin, for sure it is not came from the inlay or plastic blister as well.Although it is not possible to confirm it, given that the packaging that we have received it is open, as well as the picture taken in the theater when the medical staff detected the event, a possibility is that there was a human involuntary contamination during the packing activity.As for our internal procedures the device must be visual inspected in order to prevent similar issues.The current analysis does not indicate an applicable systematic action.
Event or Problem Description
When the nurse opened the liner box, she noticed a black dot on the implant.The surgeon decided to use a back-up liner.

• Brand Name: FLAT PE HC LINER Ø 32 / C
• Common Device Name: FLAT LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7468344
• Report Number: 3005180920-2018-00286
• Device Sequence Number: 128091
• Product Code: LZO
• UDI-Device Identifier: 07630030807541
• UDI-Public: 07630030807541
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K120531
• 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): 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: 12/03/2022
• Device Catalogue Number: 01.26.3239HCT
• Device Lot Number: 176069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2018
• Initial 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