MAUDE Adverse Event Report: BIOMET UK LTD. OXF MP SLOT POST CUT GD MED; PROSTHESIS, KNEE

Model Number N/A

Device Problems Component Falling (1105); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/01/2016

Event Type  malfunction  

Manufacturer Narrative

This user facility is outside of the united states.Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.

Event Description

During a procedure, a pin on the cutting guide fell off.No patient injury or delay was reported as a result of the event.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Event Description

During a procedure, a pin on the cutting guide fell off into the patient's wound.The piece was retrieved and nothing remained in the patient.There was a delay of approximately 15 minutes as a result of the event.

Manufacturer Narrative

This follow up report is being filed to relay product evaluation results.Review of manufacturing history found no evidence of product nonconformance.Dimensional analysis performed revealed the device conformed to specifications.Examination of the returned device revealed a tarnished appearance and excessive damage, evidence of extensive use and multiple sterilizations.The spring and plug had no evidence of residue.A conclusive root cause of the event cannot be determined with the available information.

• Brand Name: OXF MP SLOT POST CUT GD MED
• Type of Device: PROSTHESIS, KNEE
• 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: daniel tilbury ; waterton industrial estates; bridgend ; 0441656655
• MDR Report Key: 5780529
• MDR Text Key: 49131152
• Report Number: 3002806535-2016-00550
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 32-422981
• Device Lot Number: ZB140602
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1