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

Catalog Number	01.26.3239HCT
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 27 june 2017 the cleaning and packaging manager performed a visual inspection of the retrieved liner and commented as follows: the involved liner was visual inspected and the claimed defect was confirmed.It must be considered that: - as per internal instruction, the operator must check the homogeneity of the surface and the absence of slivers on each implant of the lot; - the sliver found on the liner is a process residue clearly detectable, so it can be reasonably excluded that the operator could have failed in detecting it, but it seems more probable that during this check the sliver was hidden in the clipping area and consequently difficult to be noticed.Batch review performed on 10 july 2017.Lot 166709: (b)(4) items manufactured and released on 03 january 2017.Expiration date: 2021-12-01.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.
Event or Problem Description
The surgeon and the supporting nurse detected that a small polyethylene sliver is standing away from the inly after opening the wrapping.The surgeon decided not to implant this inlay.He used a new inlay of the same reference and implanted it without any problems.

• Brand Name: VERSAFITCUP FLAT PE HC LINER Ø 32 / C
• Common Device Name: FLAT PE LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6710269
• Report Number: 3005180920-2017-00373
• Device Sequence Number: 969413
• Product Code: LZO
• UDI-Device Identifier: 07630030807541
• UDI-Public: 07630030807541
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 07/13/2017

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: 12/01/2021
• Device Catalogue Number: 01.26.3239HCT
• Device Lot Number: 166709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2017
• Initial Report FDA Received Date: 07/13/2017
• 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