MAUDE Adverse Event Report: ZIMMER BIOMET / RELIGN CORPORATION ZIMMER BIOMET RELIGN ¿ TRICERA 3 IN 1 SHAVER SYSTEM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number R-10023

Device Problems Peeled/Delaminated (1454); Contamination /Decontamination Problem (2895); Material Protrusion/Extrusion (2979)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/23/2022

Event Type  malfunction  

Event Description

The operating room recently initiated a trial on the zimmer biomet relign - tricera 3 in 1 shaver system.The system was brought in, brand new, in boxes last week and was used shortly thereafter.The shavers were returned to sps for cleaning.An amber-colored foreign remnant came out of the shaver.Upon further inspection with the baroscope, it was revealed that the lining of the inner lumen of the shaver had peeled off leaving areas of unintended rough surfaces, uneven edges, and protrusions.The shavers were immediately taken out of use for patient safety reasons.The zimmer biomet rep was notified of this issue and later provided a letter from his company's vice president/manager stating that the "ambercolored material is epotek med-353nd, an iso 10993 tested/fully compliant biocompatible/high temperature epoxy used in the standard manufacturing of the shaver handpiece as a bonding agent, which takes an amber appearance when fully cured".The letter went on to assure us that the material is safe and should be of no concern for patient safety.There remains the issue of the compromised lining of the lumen.Areas where the material has peeled off leaves crevices, rough surfaces, and openings that may potentially harbor debris that cannot be reached using the manufacturer recommended flushes and brushes; therefore, proper sterilization cannot be assured.The integrity of the shaver lumen is, indeed, questionable against industry standards for cleaning his poses a risk to patient safety.Fda safety report id# (b)(4).

• Brand Name: ZIMMER BIOMET RELIGN ¿ TRICERA 3 IN 1 SHAVER SYSTEM
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ZIMMER BIOMET / RELIGN CORPORATION
• MDR Report Key: 14566063
• MDR Text Key: 293171905
• Report Number: MW5110011
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: R-10023
• Device Catalogue Number: R-10023
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1