MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SCREWS: MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 35; ACETABULAR BONE SCREW

Catalog Number	01.32.6535
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 25 september 2019: lot 168798: (b)(4) items manufactured and released on 22-feb-2017.Expiration date: 2022-02-13.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.Additional implant involved in this event: screws: mpact 01.32.6535 cancellous bone screw, flat head ø 6,5 l 45 (k103721) lot.115666a, batch review performed on 25 september 2019: lot 115666a: (b)(4) items manufactured and released on 31-july-2017.Expiration date: 2022-07-16.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
During screw implantation the first one went over the hole and the second one remained not totally screwed in the cup hole.The surgeon decided to remove the screws and to left the cup in place without screws.The surgery was completed successfully.

• Brand Name: SCREWS: MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 35
• Common Device Name: ACETABULAR BONE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9165881
• Report Number: 3005180920-2019-00864
• Device Sequence Number: 345596
• Product Code: LPH
• UDI-Device Identifier: 07630030812408
• UDI-Public: 07630030812408
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K103721
• 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): 10/08/2019

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: 02/13/2022
• Device Catalogue Number: 01.32.6535
• Device Lot Number: 168798
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 10/08/2019
• 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