MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT CANCELLOUS BONE SCREW 65 L 25 MM; FIXATION BONE SCREW

Catalog Number 01.32.6525

Device Problems Break (1069); Detachment Of Device Component (1104); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/11/2014

Event Type  Injury  

Event Description

When inserting the fixation screw into the mpact cup using a hexagonal driver, the screw head was broken.It was impossible to remove the broken screw body and the surgeon finished the surgery leaving it in place.Mfr ref # 300518092-2014-00202.

• Brand Name: MPACT CANCELLOUS BONE SCREW 65 L 25 MM
• Type of Device: FIXATION BONE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; castel san pietro ; SZ
• Manufacturer (Section G): MEDACTA USA INC.; 1556 w carroll ave; chicago IL 60607 000
• Manufacturer Contact: 1556 w carroll ave; chicago, IL 60607-0000
• MDR Report Key: 4420344
• MDR Text Key: 5371666
• Report Number: 3006639916-2014-00202
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/09/2015

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
• Device Operator: Other
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 01.32.6525
• Device Lot Number: 130451
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/09/2015
• Distributor Facility Aware Date: 01/09/2015
• Device Age: 21 MO
• Date Report to Manufacturer: 01/09/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/09/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention