MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: CC E CC LIGHT FLAT PE HC LINER Ø 36 / F; PE FLAT LINER

Catalog Number	01.26.3648HCT
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 11 october 2018.Lot 180143: (b)(4) items manufactured and released on 08 may 2018.Expiration date: 2022-09-24.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Other piece involved: liner cc e cc light flat pe liner ø 32 / e reference 01.26.3244stt (k103352).Lot 180131: (b)(4) items manufactured and released on 06 may 2018.Expiration date: 2022-09-24.No pieces have been sold up to now.Investigation performed by washing and packaging manager on 11 october 2018.Immediately after the receipt of the complaint we checked the entire lot 180131 ((b)(4) pieces).All pieces were found.The pictures received "confirme" that the components were mixed up and the immediate check confirmed the mix up of the components.During the investigation we discovered that the two lots were processed at the carton box stage on the same day.Moreover, both lots are involved in a anomaly, both lots were reworked in the cleaning room.During the matching of the pieces with the packaging the operator wrongly associated the pieces with their box.Due to the event the procedure has been reviewed, the operators have been made aware about the issue and a computerised systems have been introduced in order to prevent similar events.
Event or Problem Description
During surgery the surgeon went to use an implant that was packaged in a box labelled as a 36/f liner.When the surgeon implanted the liner into a 56mm cc trio cup, the liner seemed to be too small.Upon further investigation, the agent and surgeon noticed that the box and stickers were labelled with 36/f yet the implant and implant blister pack was labelled 32/e liner.The agent used a second implant to complete the case.

• Brand Name: LINER: CC E CC LIGHT FLAT PE HC LINER Ø 36 / F
• Common Device Name: PE FLAT LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7955804
• Report Number: 3005180920-2018-00770
• Device Sequence Number: 11183016
• Product Code: LZO
• UDI-Device Identifier: 07630030807688
• UDI-Public: 07630030807688
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K103352
• 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): 10/11/2018

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: 09/24/2022
• Device Catalogue Number: 01.26.3648HCT
• Device Lot Number: 180143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 10/11/2018
• 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