MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CANNULATED STRAIGHT DRIVER; SHOULDER, INSTRUMENTS

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 04/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00430703046 glenoid instrument 46 mm straight spoke reamer assembly 62629914.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 01553.

Event Description

It was reported the initial shoulder arthroplasty, the reamer broke off the handle.No patient was involved during the malfunction.No additional information is available.

Manufacturer Narrative

Upon reassessment of the reported event this product is determined to be not reportable as no allegations were reported towards the driver.The initial report was submitted in error and needs to be voided.

Event Description

Upon reassessment of the reported event this product is determined to be not reportable as no allegations were reported towards the driver.The initial report was submitted in error and needs to be voided.

• Brand Name: CANNULATED STRAIGHT DRIVER
• Type of Device: SHOULDER, INSTRUMENTS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8519272
• MDR Text Key: 142120277
• Report Number: 0001822565-2019-01554
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K103404
• 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: 06/20/2019

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 Model Number: N/A
• Device Catalogue Number: 00430707400
• Device Lot Number: 62356352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/04/2019
• Initial Date FDA Received: 04/16/2019
• Supplement Dates Manufacturer Received: 06/14/2019
• Supplement Dates FDA Received: 06/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1