MAUDE Adverse Event Report: BIOMET ORTHOPEDICS TIBIAL CUT GUIDE RIGHT MEDIAL 5 DEGREES; INSTRUMENT, KNEE

Model Number N/A

Device Problem Difficult To Position (1467)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned for evaluation examination of the reported device was not possible as it was not returned.Visual and dimensional evaluations could not be performed.A review of device history records identified no related manufacturing deviations or anomalies that would have contributed to the reported event; the device is considered to have met its specifications at the time it was sent to distribution.The investigation can draw no conclusions with the information made available.Based on the inability to determine root cause, the need for corrective, preventative, or field action(s) have not been indicated as a result of this investigation.Zimmer biomet considers the investigation closed at this time.If any further information is found which would change or alter any conclusions or information, a follow-up report will be filed accordingly.Not returned to manufacturer.

Event Description

It was reported that a patient underwent right partial knee arthroplasty.During the procedure the surgeon noted that it was not easy to position the tibial cut guide and the vertical cut was made severely to the lateral side of the guide.

• Brand Name: TIBIAL CUT GUIDE RIGHT MEDIAL 5 DEGREES
• Type of Device: INSTRUMENT, KNEE
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6816909
• MDR Text Key: 83502286
• Report Number: 0001825034-2017-06755
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 42539905285
• Device Lot Number: 63512100
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 115