MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SCREWS: MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 30

Catalog Number	01.32.6530
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 14 august 2019: lot 1902135: (b)(4) items manufactured and released on 2-apr-2019.Expiration date: 2024-03-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one other similar reported event.Preliminary investigation performed by r&d project manager: preliminary investigation performed on 03 september 2019.The head of the screw sheared off from the body and the image show the head still connected with the related screwdriver.The root cause of this event can be related to an excessive flexion applied to the screw during insertion, but from the received information it is not sufficient to determine it with certainty.
Event or Problem Description
During the primary hip surgery, and while the surgeon was manually inserting the screw into the acetabulum, the screw head sheared off.The shaft of the screw was left inside of the patient's acetabulum and the screw head was recovered.There was no delay in the case and the surgery was completed successfully.

• Brand Name: SCREWS: MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 30
• Common Device Name: CANCELLOUS BONE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8964023
• Report Number: 3005180920-2019-00741
• Device Sequence Number: 10810121
• Product Code: LPH
• UDI-Device Identifier: 07630030812392
• UDI-Public: 07630030812392
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/05/2019

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: 03/19/2024
• Device Catalogue Number: 01.32.6530
• Device Lot Number: 1902135
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 09/05/2019
• 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