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

Catalog Number SBGL3701

Device Problem Fracture (1260)

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

Event Date 12/22/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: compr tt shldr gd and bn r, cat#: 20809000202, lot#: 64969681.Glen augment reamer sz 4, cat#: sbgl3704, lot#: ni.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records, lot identification was not provided.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

It was reported during a total shoulder arthroplasty, the surgeon planned to use an augmented glenoid implant.He prepared the glenoid per the technique placing the augment reamer guide into the reamed hole.He then tried to use the gold augment reamer and struggled getting it into the reamer guide.Finally getting it placed, he went to ream with the reamer shaft which promptly fractured.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.The following sections were updated: b4, b5, d4, d9, g3, g6, h2, h3, h4, h6, h10.Visual examination of the returned product identified that the augment reamer driver is fractured near the hex ball tip.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.Device was submitted for further analysis.Analysis determined that the fracture surface artifacts indicated a ductile torsional overload fracture.Xrf analysis found the reamer driver material to be 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.

Event Description

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

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: GLENOID ORTHOPAEDIC REAMER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11174170
• MDR Text Key: 227070671
• Report Number: 0001822565-2021-00064
• 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,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: 01/08/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/23/2020
• Initial Date FDA Received: 01/14/2021
• Supplement Dates Manufacturer Received: 04/13/2021; 10/19/2021
• Supplement Dates FDA Received: 05/05/2021; 10/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10