MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VERSA-DIAL MODULAR HUMERAL HEADS TRIAL 46MM X 27MM X 46MM; TEMPLATE

Model Number N/A

Device Problem Residue After Decontamination (2325)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/07/2016

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show the lot released with no recorded anomaly or deviation.Review of manufacturing history found no evidence of product nonconformance.Examination of the trial confirms the reported condition, as foreign material on the device tested (b)(6) for hemoglobin.User facility¿s sterilization technique was reviewed and confirmed to be conforming to manufacturer instruction.It is likely that there was an improper cleaning technique used at some point during the trial¿s 4 years of use; however, a conclusive root cause of the event cannot be determined with the available information.There are warnings in the package insert that state that this type of event can occur: under cleaning and decontamination, number 2 states, "disassembly-the majority of surgical instruments and trial prostheses are constructed in such a way that they will not require disassembly.However, some of the more complex instruments are made of several components and these should be disassembled into their individual parts prior to decontamination.In most cases the method of disassembly is self-evident.Loosen and/or disassemble instruments with removable parts.Screws or bolts on some instruments can be loosened for cleaning but are self-retaining to prevent loss.Particular attention should be taken to remove all debris from all cannulations, crevices, serrations, and obscure holes in the instruments." number 3 states, "washing/disinfecting- it is recommended that the instruments, disassembled as required, be decontaminated using an automatic washer-disinfection unit utilizing thermal disinfection.This should preferably be of the ultrasonic or continuous tunnel process type." this report is number 6 of 10 mdrs filed for the same patient (reference 1825034-2016-04155 - 04164).

Event Description

During sterilization, blood contaminate was noted on disassembled parts of the trial head.There was no patient injury or delay in a procedure as a result of the event.

Manufacturer Narrative

Further investigation was conducted on the reported issue, and the root cause was updated accordingly.Further evaluation relayed that this issue is determined to be a design related issue.The parts were determined to be manufactured non-conforming.A design change has been initiated to address the reported event.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: VERSA-DIAL MODULAR HUMERAL HEADS TRIAL 46MM X 27MM X 46MM
• Type of Device: TEMPLATE
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 6039816
• MDR Text Key: 57859790
• Report Number: 0001825034-2016-04160
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 407248
• Device Lot Number: ZB120702
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1