MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD PS BOX REAMER 55-60MM

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 09/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that multiple instruments fractured resulting in a twenty minute delay.Surgery was completed with another instrument.No additional information is available at this time.

Event Description

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

Manufacturer Narrative

The reported event was considered confirmed as the photograph that was provided shows tip fractured.Device history record (dhr) was reviewed for deviations and/ or anomalies with no relevant deviations / anomalies identified.A field communication was sent out explaining the optimal use of a ps box mill.It is mentioned that " ensure that the reamer is fully seated on the ps box mill pivot, maintain the reamer position perpendicular to the axis of the pivot and avoid applying excessive force when milling.Use only as much force as necessary to aid the reamer¿s advancement through the bone." however, without inspecting (testing) the products a root cause cannot 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: VNGD PS BOX REAMER 55-60MM
• Type of Device: REAMER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7980921
• MDR Text Key: 125638662
• Report Number: 0001825034-2018-09819
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• 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: 32-487230
• Device Lot Number: 033800
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 80