MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GLENOID INSTRUMENT 52 MM STRAIGHT SPOKE REAMER ASSEMBLY; EXTREMITIES, INSTRUMENT

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/12/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.Product not returned.

Event Description

It was reported that during the procedure, the glenoid reamer fractured.One of the fractured pieces was identified on an inter operative x-ray and removed.The procedure was completed using another product.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h1, h2, h3, h6, h10.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 available at the time of this report.

• Brand Name: GLENOID INSTRUMENT 52 MM STRAIGHT SPOKE REAMER ASSEMBLY
• Type of Device: EXTREMITIES, INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9437271
• MDR Text Key: 169824929
• Report Number: 0001822565-2019-05198
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K103404
• 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: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 00430703052
• Device Lot Number: 62289398
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/13/2019
• Initial Date FDA Received: 12/09/2019
• Supplement Dates Manufacturer Received: 01/07/2020
• Supplement Dates FDA Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other