MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SCREWS: MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 25

Catalog Number	01.32.6525
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 20 may 2019: lot 187778: (b)(4) items manufactured and released on 17-oct-2018.Expiration date: 2023-10-08.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.Visual inspection performed by r&d project manger: the screw head is broken at the base of the neck.From the received piece it is not possible to determine with certainty the root cause of the event, but we can consider a possible wide bending moment applied to the screw during its insertion in the acetabulum that led to the breakage of the head.Clinical evaluation performed by medical affairs director: intraoperative fracture of an acetabular bone screw.Threaded fragment remained in the pelvis but this will not cause any adverse effect.The cause of the event is not clinical.
Event or Problem Description
During the primary hip surgery and after drilling a hole in the acetabulum for screw placement, the head of the 25mm mpact dome screw broke off while the surgeon was implanting it into the acetabulum.The broken screw fragment was recovered but the threaded portion of the screw was left in the acetabulum.The surgeon was able to successfully place a 15mm mpact dome screw into the second hole of the mpact 2-hole cup and the cup was well fixated.The surgery was completed successfully.

• Brand Name: SCREWS: MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 25
• Common Device Name: CANCELLOUS BONE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8640291
• Report Number: 3005180920-2019-00408
• Device Sequence Number: 380975
• Product Code: LPH
• UDI-Device Identifier: 07630030812385
• UDI-Public: 07630030812385
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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): 05/24/2019

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: 10/08/2023
• Device Catalogue Number: 01.32.6525
• Device Lot Number: 187778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 05/24/2019
• 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