MAUDE Adverse Event Report: BIOMET UK LTD. BM ACET LP DOME SCW TI S/TAP DIA6.5X30MM; LOW PROFILE SCREW

Model Number N/A

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/11/2014

Event Type  Injury  

Event Description

It was reported that during a hip arthroplasty on (b)(6) 2014, the acetabular screw broke upon insertion.The tip of the screw was left in the patient.No further information has been received.

Manufacturer Narrative

The user facility is outside of the united states.No medwatch report was received.Current information is insufficient to permit a conclusion as to the cause of the event.No further complications have been reported.Item is to be returned.Upon item return and completion of evaluation, a follow up report will be sent to the fda.

Manufacturer Narrative

The conclusion of the investigation is that the screw was put under excessive stress, possibly due to the screw not being concentric with the hole, and being placed under a shear load as it began to locate on the head, or the hole was drilled slightly shallow (cannot be confirmed), causing more force to be applied to screw it in and failed as a result.It cannot be 100% confirmed that the screw conformed to specification when it left biomet as only the head is available, but all measurements taken on the head suggest it did.No measurements were taken over the little thread left as it was very probably distorted due to the failure.Without further information, no additional conclusions can be drawn.

• Brand Name: BM ACET LP DOME SCW TI S/TAP DIA6.5X30MM
• 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: 4164293
• MDR Text Key: 4773026
• Report Number: 3002806535-2014-00228
• 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,Followup
• Report Date: 10/24/2014

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: 103533
• Device Lot Number: 3061436
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2014
• Initial Date FDA Received: 10/10/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2013
• 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): Disability