MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GLENOID REAMER MED ER MED; INSTRUMENT, SHOULDER

Model Number N/A

Device Problem Misassembled (1398)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Udi # n/a.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.Not returned to manufacturer.

Event Description

It has been reported that during total shoulder arthroplasty, the reamer split when it was being removed from the shaft.No adverse events have been reported as a result of the malfunction.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

Report source foreign: (b)(6).Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified this reamer is four years old and show signs of wear and tear.The tooth detail is worn and dinged.The device is split on the outer edge of the reamer.Dhr was reviewed and no discrepancies were found.A definitive root cause cannot be determined.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: GLENOID REAMER MED ER MED
• Type of Device: INSTRUMENT, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8460595
• MDR Text Key: 140953796
• Report Number: 0001825034-2019-01455
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• 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: 406633
• Device Lot Number: 249450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1