MAUDE Adverse Event Report: BIOMET UK LTD. HIPLOC SYSTEM 130DEG PLATE 38MM BARREL 4 HOLE PLATE; DEVICE, FIXATION

Model Number N/A

Device Problem Incorrect Device Or Component Shipped (2962)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during a procedure, it was found the plate and screw inside the packaging did not match the label.Another plate and screw of the correct size were used to complete the procedure without delay.No further information has been provided.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.It was found the hiploc plate was incorrectly marked with the angulation and reference number.Investigation results concluded that the reported event was due to human error that occurred during the set up resulting in a correct marking of the lot number and an incorrect marking of the part number and the angulation.Corrective action has been initiated to address reported issue.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: HIPLOC SYSTEM 130DEG PLATE 38MM BARREL 4 HOLE PLATE
• Type of Device: DEVICE, FIXATION
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6722995
• MDR Text Key: 80523212
• Report Number: 3002806535-2017-00601
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: PK080685
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2017
• 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: 2110-130-004
• Device Lot Number: 2017010783
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2017
• 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