MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD PS BOX REAMER 55-60MM 0MM; KNEE INSTRUMENT

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Report source: foreign: (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 during surgery the instrument tip fractured and another one was used.No injury to patient.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

This follow-up report is being submitted to relay updated and additional information.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product confirmed the tip of the reamer had fractured.The returned product was submitted to sem lab for fracture and material analysis.The fracture surface aligned with what is reported in summary of failure analysis of vanguard box reamer tip fractures.Material analysis confirmed that the material composition is consistent with the print.Dhr was reviewed and no discrepancies were found.Investigation results concluded that the reported event was attributed to user error as returned reamer experienced a bending overload fracture indicating that excessive force was applied.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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.

• Brand Name: VNGD PS BOX REAMER 55-60MM 0MM
• Type of Device: KNEE INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8568956
• MDR Text Key: 143697957
• Report Number: 0001825034-2019-01962
• Device Sequence Number: 1
• Product Code: HTO
• 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: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: ZB110801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/08/2019
• Initial Date FDA Received: 05/01/2019
• Supplement Dates Manufacturer Received: 10/08/2019
• Supplement Dates FDA Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1