MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CERVICAL PLATE FIXED SELF-DRILLING SCREW DIAM. 4X16MM (2X)

Catalog Number	03.70.157
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 10 july 2018; lot 1620220: (b)(4) items manufactured and released on 13 october 2016.Expiration date:2021-09-25; 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.
Event or Problem Description
The screw broke during insertion (acdf) with drivers 03.70.0032 and 03.70.0033.Part of the screw fell into the patient, the surgeon was able to recover the broken part and fragments.A second screw was used, there was a five minutes delay.
Additional Manufacturer Narrative
To date, the device was not received for investigation.No information about its effective availability.Preliminary investigation performed by r&d project manager: although no definitive root cause can be established, it is most likely that a non-standard action occurred during the device application that results in an abnormally high stress on the device.This type of breakage has not been identified as a systemic issue of the device, and the batch record review does not indicate any potential manufacturing related issue.

• Brand Name: CERVICAL PLATE FIXED SELF-DRILLING SCREW DIAM. 4X16MM (2X)
• Common Device Name: FIXED SELF-DRILLING SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7685674
• Report Number: 3005180920-2018-00508
• Device Sequence Number: 11080011
• Product Code: KWQ
• UDI-Device Identifier: 07630030840944
• UDI-Public: 07630030840944
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2018

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: 09/25/2021
• Device Catalogue Number: 03.70.157
• Device Lot Number: 1620220
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2018
• Supplement Date Received by Manufacturer: 06/15/2018
• Initial Report FDA Received Date: 07/13/2018
• Supplement Report FDA Received Date: 10/03/2018
• 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: 57 YR