MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL CUT GUIDE LEFT MEDIAL 5 DEGREES; INSTRUMENT, KNEE

Model Number N/A

Device Problem Mechanical Jam (2983)

Patient Problem No Information (3190)

Event Date 07/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Udi#: (b)(4).Foreign, (b)(6).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that after guide was installed, oblique pin was jammed upon insertion and could not be removed from the guide.Subsequently, another guide and pin were used to complete the procedure.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual inspection of the returned device exhibited signs of repeated use, as well as burrs present inside the holes, which resulted in a dimension failure.However, the complaint cannot be confirmed as the tibial cut guide was returned with the pin disengaged.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.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: TIBIAL CUT GUIDE LEFT MEDIAL 5 DEGREES
• Type of Device: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8711599
• MDR Text Key: 148413323
• Report Number: 0001825034-2019-02616
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42539905185
• Device Lot Number: 63786032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: CAT#00590102000 BIOMET DRILL PIN LOT#64086344; CAT#00590102000 BIOMET DRILL PIN LOT#64086344