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

Catalog Number	01.32.6535
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2019 lot 1902136: 189 items manufactured and released on 23-apr-2019.Expiration date: 2024-03-26.No anomalies found related to the problem.To date, 63 items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
During the primary hip surgery, while the surgeon was drilling a hole for the screw into the acetabulum, the drill bit broke.Also while screwing into the acetabulum, a screw warped.The surgeon had a back-up drill bit and a screw and completed the case by using them.There was no delay in the case and the surgery was completed successfully.
Additional Manufacturer Narrative
On december 6th 2019 it was communicated that the devices are not available.
Additional Manufacturer Narrative
Manufacturing process review batch released on date: (b)(6) 2018 n.Of pieces released: (b)(4).Comments: all the steps, according to our routing sheet and relative drawings, have been performed correctly as well as the dimensional and functional controls.Conclusions: there aren't non conformity elements in the document review.

• Brand Name: SCREWS: MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 35
• Common Device Name: CANCELLOUS BONE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9171456
• Report Number: 3005180920-2019-00851
• Device Sequence Number: 2734743
• Product Code: LPH
• UDI-Device Identifier: 07630030812408
• UDI-Public: 07630030812408
• 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
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/18/2019

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: 03/26/2024
• Device Catalogue Number: 01.32.6535
• Device Lot Number: 1902136
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2019
• Supplement Date Received by Manufacturer: 09/09/2019; 09/09/2019
• Initial Report FDA Received Date: 10/09/2019
• Supplement Report FDA Received Date: 11/12/2019; 12/18/2019
• 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