MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD SHORTQUICK RELEASE DRILL; INSTRUMENT, KNEE

Model Number N/A

Device Problem Mechanical Jam (2983)

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

Event Date 11/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant devices - vanguard quick release trocar pin 2pk catalog #: 32-486255 lot #: ni, vanguard quick release trocar pin 2pk catalog #: 32-486255 lot #: ni, vanguard distal cut block without handle catalog #: 32-487002 lot #: ni.Report source - foreign: (b)(6).The complainant has not yet indicated whether the devices are being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this patient; please see all reports associated with this event.0001825034-2019-05157, 0001825034-2019-05159, 0001825034-2019-05160, 0001825034-2019-05161.Investigation incomplete.

Event Description

It is reported that during knee arthroplasty while pinning the slot to trim the distal femur, one of the pins became stuck in the hole of the cutting block and the other became stuck within the drill.No adverse events were reported as a result of this malfunction.

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.

Manufacturer Narrative

This follow-up report is being submitted to relay updated and additional information.Reported event was confirmed by review of photograph.Photograph provided confirms that the drill is stuck in the driver and the cut guide.Dhr was reviewed and no discrepancies 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.

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.The following sections were updated: b4; b5; d9; g3; g6; h1; h2; h3.Visual inspection of the returned quick release drill was found to exhibit signs of repeated use (scratched / gouged) and has one trocar pin seized in the release drill.Medical records were not provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

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

• Brand Name: VANGUARD SHORTQUICK RELEASE DRILL
• Type of Device: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9327518
• MDR Text Key: 179532499
• Report Number: 0001825034-2019-05160
• Device Sequence Number: 1
• Product Code: HTW
• 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,Followup,Followup
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• 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: 32-486259
• Device Lot Number: ZB090120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1