MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 30

Catalog Number 01.32.6530

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/05/2016

Event Type  malfunction  

Manufacturer Narrative

Additional information received from the initial reporter on 19 april 2016 and includes: the event did not cause any critical delay in the surgery.Batch review performed on 09 may 2016.(b)(4).Not available for the moment.

Event Description

Cancellous bone screw head was broken during surgery.The distal part was left in the patient.A second screw of 35mm was inserted in a second cup hole.

Manufacturer Narrative

Additional information received on 21 september 2016 and includes: the screw is not available for investigation.

• Brand Name: MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 30
• Type of Device: CANCELLOUS BONE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, 6874 ; SZ 6874 ; 91 6966060
• MDR Report Key: 5650491
• MDR Text Key: 46214759
• Report Number: 3005180920-2016-00216
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K103721
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/21/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 01.32.6530
• Device Lot Number: 130452
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/12/2016
• Initial Date FDA Received: 05/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/21/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/13/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 38 YR