MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA 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	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 08 october 2018; lot 175733: (b)(4) items manufactured and released on 15 november 2017.Expiration date: 2022-10-22; 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.On 08 october 2018 the r&d project manager made the following analysis, while checking an image of the broken item: the head of the screw is broken as mentioned in the description of the complaint.The key of the correct preparation of the pre-hole is the correct use of the drill guide; we do not know which is the drill guide used by the surgeon, so we cannot be sure regarding the correct inclination of the hole.The possible uncorrect inclination of the hole could be the root cause of the event.During the insertion of the screw it is possible that the user applied a bending force of the screw to correct the inclination instead of recreate the hole with a correct direction.This operation could lead to the breakage of the screw, but from the received information it is not possible to determine with certainty the root cause of the event.Considerations: even in case of wrong preparation of the hole, a flexible screwdriver is available to avoid the transfer of excessive stress to the head of the screw and the consequently breakage of it.
Event or Problem Description
During screw tightening, the screw head snapped off.The surgeon used the appropriate mpact screwdriver to introduce and tighten the screw.The broken screw body was left in situ.The surgery was anyway completed successfully.

• Brand Name: 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, switzerland 6874 ; SZ 6874
• MDR Report Key: 7943004
• Report Number: 3005180920-2018-00763
• Device Sequence Number: 1435470
• Product Code: LPH
• UDI-Device Identifier: 07630030812392
• UDI-Public: 07630030812392
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 10/08/2018

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: 10/22/2022
• Device Catalogue Number: 01.32.6530
• Device Lot Number: 175733
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2018
• Initial Report FDA Received Date: 10/08/2018
• 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: 58 YR