MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 40

Catalog Number	01.32.6540
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 13 december 2017.(b)(4).
Event or Problem Description
When the surgeon was implanting the screw, the screw bent.The surgeon used a secondary screw to complete the surgery.There was a 10 minute delay in surgery.The surgery was completed successfully.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager on 12 jan 2018: the screw was analyzed.It was noticed that the entire head (the part without the helix) was completely bent by more or less 10 degrees.The fact is probably due to an incorrect preparation of the drilled hole: 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 have led to the bending of the screw, but from the received information it is not possible to determine with certainty the root cause of the event.

• Brand Name: MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 40
• Common Device Name: CANCELLOUS BONE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7117208
• Report Number: 3005180920-2017-00739
• Device Sequence Number: 1358171
• Product Code: LPH
• UDI-Device Identifier: 07630030812415
• UDI-Public: 07630030812415
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/02/2022
• Device Catalogue Number: 01.32.6540
• Device Lot Number: 168800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/14/2017
• Supplement Date Received by Manufacturer: 11/14/2017
• Initial Report FDA Received Date: 12/14/2017
• Supplement Report FDA Received Date: 01/12/2018
• 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