MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GLEN AUGMENT REAMER SZ 4; GLENOID ORTHOPAEDIC REAMER

Catalog Number SBGL3704

Device Problem Fracture (1260)

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

Event Date 12/17/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: augment reamer driver, cat#: sbgl3701, lot#: 64626369.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.

Event Description

It was reported that the surgeon attempted to push the gold size 4 augment reamer into the augment reamer guide with the augment reamer driver.It is unknown if the reamer was completely into the reamer guide when he pulled the trigger of the power reamer.The driver tip fractured and it appears the gold size 4 augment reamer was damaged as well.The glenoid was prepared by hand.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.Visual examination of the returned reamer pn sbgl3704 found that the device was bent and no fractured.Xrf analysis found that the reamer material was consistent with 455 stainless steel alloy.Review of the device history record(s) identified no deviations or anomalies during manufacturing.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: GLEN AUGMENT REAMER SZ 4
• Type of Device: GLENOID ORTHOPAEDIC REAMER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11107905
• MDR Text Key: 226264174
• Report Number: 0001822565-2020-04265
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K193180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SBGL3704
• Device Lot Number: 64624282
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1