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

Catalog Number	01.32.6520
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information received on 19 january 2018 by medacta (b)(4): drill holder was not a medacta's product.Clinical evaluation performed by medical affairs on 02 february 2018: during surgery, the cancellous bone screw could no be fully inserted.The screw was changed to a smaller one.According to the report, the surgery was prolonged of 10 minutes and no metal debris was found in the surgical field.No negative consequences are expected for the patient.No clinical cause for this problem can be identified.Batch review performed on 07 february 2018, lot 173317: (b)(4) items manufactured and released on 10 october 2017.Expiration date: 2022-09-26, 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 on 01 february 2018 by r&d project manager: the photo of the screw and the received part were analyzed.It was noticed that the thread of the screw was partially separated.During the insertion, the thread got in contact with the wall of the seat of the screw head; this may be due to the fact that the core hole was incorrect for the safe insertion of the screw.This problem is probably related to the use of a drill guide not supplied by medacta: with different drill guides, medacta can not certificate that the inclination angle of the hole is correct.A correct core hole (with a proper inclination), allows the insertion of the screw without impingement with the cup, avoiding breakages of the first.The core hole that ensures a proper insertion of cancellous bone screws is ø3.2mm.Medacta cancellous bone screws have a core diameter of 3mm, while the external diameter is 6.5mm.A drill bit ø3.2mm and a self-tapping design of the tip of the screw allow a correct insertion of the screw.The insertion should be guaranteed for the different hardnesses of the bone.
Event or Problem Description
The surgeon had difficulty placing the cancellous bone screw ø6.5 l20 (the screw thread was damaged during surgery).The surgeon used a cancellous bone screw ø6.5 l15 to complete the surgery.

• Brand Name: 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: 7259381
• Report Number: 3005180920-2018-00035
• Device Sequence Number: 16449686
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/09/2018

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: 09/26/2022
• Device Catalogue Number: 01.32.6520
• Device Lot Number: 173317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2018
• Initial Report FDA Received Date: 02/09/2018
• 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: 69 YR