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

Catalog Number	01.26.65.35
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 20 may 2019.Lot 153636: (b)(4) items manufactured and released on 23-sep-2015.Expiration date: 2020-06-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Visual inspection performed by r&d project manager: the screw is broken in the base of the head with a cut orthogonal to the axis of the screw.From the received piece it is not possible to determine the root cause of the event with certainty; a possible reason can be related to a high bending moment applied to the screw during its insertion.
Event or Problem Description
Cancellous bone screw flat head broke during the process of adjusting the screw.The body of the screw remained in the acetabulum and it was not possible to take it out.The surgeon reviewed that no part of the body of the screw was out, avoiding some touch / rub when the liner hc uhmwpe was implanted.The surgery completed successfully, the body of the screw was well seated.

• Brand Name: CANCELLOUS BONE SCREW FLAT HEAD Ø 6,5 L 35
• Common Device Name: HIP CANCELLOUS BONE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8631622
• Report Number: 3005180920-2019-00397
• Device Sequence Number: 1858378
• Product Code: LZO
• UDI-Device Identifier: 07630030808357
• UDI-Public: 07630030808357
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2019

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: 06/30/2020
• Device Catalogue Number: 01.26.65.35
• Device Lot Number: 153636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2019
• Initial Report FDA Received Date: 05/22/2019
• 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: 31 YR