MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM REAMER GUIDE, BONE & IMPLANT MODEL; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product code - phx.It is indicated that the product will not be returned to zimmer biomet for investigation, as no response has yet been received from the customer regarding the whereabouts of the device.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Udi# - (b)(4).Concomitant devices - comprehensive vault reconstruction system glenoid w/ f.A.S.T.Guides catalog #: 110027734 lot #: 435890.

Event Description

It is reported that the custom vault reconstruction system guides did not fit the patient during shoulder arthroplasty.No adverse events have been reported as a result of this malfunction.Attempts have been made to obtain additional information and further information is not available at this time.

Manufacturer Narrative

(b)(4).The reported event could not be confirmed based on limited information received.No device was returned for evaluation, therefore, no visual or dimensional inspections were conducted.Device history record¿ (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.The final design notice for the custom device was signed by the surgeon.A definitive root cause cannot be determined with the information provided.No corrective actions, preventive actions, or field actions resulted after investigation of this 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: COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM REAMER GUIDE, BONE & IMPLANT MODEL
• Type of Device: PROSTHESIS, SHOULDER
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6664131
• MDR Text Key: 78458472
• Report Number: 0001825034-2017-04250
• Device Sequence Number: 1
• Product Code: MJT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PCUSTOM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 10/23/2017

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: Physician
• Device Expiration Date: 11/15/2017
• Device Model Number: N/A
• Device Catalogue Number: 110031178
• Device Lot Number: 436140
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/25/2017
• Initial Date FDA Received: 06/23/2017
• Supplement Dates Manufacturer Received: 10/23/2017
• Supplement Dates FDA Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1