MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA COCR BALL HEAD 12/14 Ø 32 SIZE L +3.5

Catalog Number	01.25.023
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 24 july 2018.Lot 166596: (b)(4) items manufactured and released on 13 march 2018.Expiration date: 2022-03-01.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.Preliminary investigation performed by packaging and washing manager on 18 july 2018.The picture received shows that the tongue use to extract the external blister is broken.It is not possible at the moment determine the root cause of the event.Further investigation will be done once received the item.Isolated case.
Event or Problem Description
Upon opening a femoral head implant, it was found the internal packaging was stuck inside the external packaging.They tried several time to get the internal packaging out but were not able to while keeping the internal packaging and implant sterile.Even outside the sterile feel the implant is extremely difficult to remove.Another femoral head was opened.
Additional Manufacturer Narrative
Visual inspection performed by packaging and washing manager on 06 september 2018 after the controlled on the returned packaging, it is possible confirme that the primary blister seems blocked into the secondary blister.We disassembled them using force, we noticed that the insert of the head moved from its original position.It is likely that the event was caused by an abnormal handling of the piece causing a deformation of the lateral side of the blister.The deformation probably caused a higher friction that caused the "welding" of the two blisters.

• Brand Name: COCR BALL HEAD 12/14 Ø 32 SIZE L +3.5
• Common Device Name: COCR BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7722401
• Report Number: 3005180920-2018-00541
• Device Sequence Number: 11398461
• Product Code: JDI
• UDI-Device Identifier: 07630030805172
• UDI-Public: 07630030805172
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K072857
• 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,Followup
• Report Date (Section B): 09/07/2018

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: 03/01/2022
• Device Catalogue Number: 01.25.023
• Device Lot Number: 166596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2018
• Supplement Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 07/26/2018
• Supplement Report FDA Received Date: 09/07/2018
• 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