MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SCREWS: MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 20

Catalog Number	01.32.6520
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 september 2019: lot 1811921: 150.Items manufactured and released on 12-feb-2019.Expiration date: 2024-02-03.No anomalies found related to the problem.To date, 108 items of the same lot have been already sold without any similar reported event.Clinical evaluation: intraoperative difficulty to place acetabular screws, that reportedly did not proceed until the end of the pre-drilled hole.One of them was then hammered in place.We do not recall a similar case description and we cannot find any clinical reason for this to happen.Technical analysis may be performed on the screw to verify dimensions.Metrological analysis: on the 2 october 2019 cq department reported the metrological analysis of this case: observations: from the documentation of lot, don't emerge anomalies; the whole dossier of manufacture is conforming to the specific project.The dimensional control, has not identified any anomaly or production defect.The device are conforming to the specifications of project.Measuring instruments used: semi-automatic optical measuring systems id no.(b)(4).Visual inspection: visual inspection performed on the screw on 25/sep/2019.The small screw appeared to be damaged in some crests of the fillet; this could be probably due to an incorrect angle between the screw and the prepared hole, that could have caused the impingement between the fillet of the screw and the rim of the acetabular hole.Moreover, quality control inspection did not detected any anomalies and out-of-specific dimensions.We cannot assert with certainty the root cause of the event, but form the received information it is possible that the insertion angle was different respect to the prepared hole and some flecting forces have been applied during hte insertion of the screw.
Event or Problem Description
The surgeon was not able to insert completely 2 cancellous bone screws of the same ref.And lot into the patient's acetabulum.Both screws blocked 5 mm before the final seat.A new drilling was performed, but the surgeon was not able to insert the screws completely.Finally he was able to insert 1 cancellous bone screw by impacting it with the hammer.At that time acetabular cup seemed to be well fixed, so the surgeon decided to don't insert the second screw.The surgery was completed successfully but with 20 minutes of delay.

• Brand Name: SCREWS: MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 20
• Common Device Name: CANCELLOUS BONE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9155336
• Report Number: 3005180920-2019-00836
• Device Sequence Number: 2830808
• Product Code: LPH
• UDI-Device Identifier: 07630030812378
• UDI-Public: 07630030812378
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2019

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: 02/03/2024
• Device Catalogue Number: 01.32.6520
• Device Lot Number: 1811921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 10/04/2019
• 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
• Patient Age: 80 YR