MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FLEXIBLE CANNULATED REAMER 6 MM DIAMETER; PROSTHESIS, ELBOW

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/26/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00840107203, flexible cannulated reamer 6.5 mm diameter, 62656833.(b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated report: 0001822565 - 2018 - 05871.

Event Description

It was reported that during an elbow arthroplasty procedure, two (2) reamers became stuck in the intramedullary canal during use.While trying to remove the reamers, they both fractured.There was a forty-five minute delay to the procedure due to the issue.No additional information is made available.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned devices shows the tip had disassembled from the shaft.Dhr was reviewed and no discrepancies were found.A definitive root cause cannot be determined.F any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No additional information is available to report at this time.

• Brand Name: FLEXIBLE CANNULATED REAMER 6 MM DIAMETER
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8015734
• MDR Text Key: 125346470
• Report Number: 0001822565-2018-05872
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• PMA/PMN Number: K123862
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00840107202
• Device Lot Number: 62813911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention