MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AUGMENT REAMER DRIVER; ORTHOPAEDIC BALL SPIKE

Catalog Number SBGL3701

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 10/16/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.The event was initially reported on 0001825034-2020-04030.

Event Description

It was reported that when reaming for the augment, the hex ball fractured off of the shaft of the reamer driver.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D4: (b)(4) visual examination of the returned product identified the item was returned because the hex ball was fractured off.Item and lot numbers are confirmed to match the complaint.Hardness was checked using gage 25-1003-690-07-a and found to be conforming.Review of the device history record 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.

Event Description

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

Manufacturer Narrative

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

• Brand Name: AUGMENT REAMER DRIVER
• Type of Device: ORTHOPAEDIC BALL SPIKE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11020041
• MDR Text Key: 221813655
• Report Number: 0001822565-2020-04054
• Device Sequence Number: 1
• Product Code: HWR
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 10/21/2021

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: Health Professional
• Device Catalogue Number: SBGL3701
• Device Lot Number: 64832651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 01/07/2021; 10/19/2021
• Supplement Dates FDA Received: 01/20/2021; 10/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1