MAUDE Adverse Event Report: BIOMET UK LTD. BMET ACET LP DOME SCW TI S/TAP Ø6.5X35MM; LOW PROFILE SCREW

Model Number N/A

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/08/2014

Event Type  Injury  

Event Description

During a hip arthroplasty surgery on (b)(6) 2014, while inserting a screw, the screw snapped and partially remained in the patient.Procedure was completed without further incident.

Manufacturer Narrative

The user facility is outside of the united states.No medwatch report was received.No further information has been received.The broken part of the screw was returned for evaluation.With the minimum of information available, it is difficult to confirm the screw conformed to the drawing.All indications are that it did, prior to leaving biomet.Marks on the underside of the head suggest the screw was being tightened into the shell at the time of breakage.The break does not suggest there was a flaw in the material.

• Brand Name: BMET ACET LP DOME SCW TI S/TAP Ø6.5X35MM
• Type of Device: LOW PROFILE SCREW
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: sian rogers ; waterton industrial estates; bridgend CF31 -3XA ; UK CF31 3XA ; 0441656655
• MDR Report Key: 3851268
• MDR Text Key: 4614971
• Report Number: 3002806535-2014-00142
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PK991807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/09/2014

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: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 103534
• Device Lot Number: 3055461
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2014
• Initial Date FDA Received: 06/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention