MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSYS TROCHANTERIC REAMER; HIP INSTRUMENT

Model Number N/A

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Information (3190)

Event Date 01/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4) (b)(6).Reporter had indicated that product will be returned.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported by the warehouse technician that the product received had a wrong device corresponding to package labeled.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Dhr was reviewed and no discrepancies were found.Product label provided in the dhr matched the label on the reamer indicating no issues with the packaging label.Reamer was likely conforming when it left zimmer biomet as there is no evidence that states otherwise.Root cause was unable to be determined as the information provided was limited.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.

Manufacturer Narrative

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: VERSYS TROCHANTERIC REAMER
• Type of Device: HIP INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7302254
• MDR Text Key: 101378761
• Report Number: 0001822565-2018-00978
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2018

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: 00789601000
• Device Lot Number: 62736089
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/30/2018
• Initial Date FDA Received: 02/28/2018
• Supplement Dates Manufacturer Received: 04/03/2018; 04/03/2018
• Supplement Dates FDA Received: 04/05/2018; 04/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2014
• 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