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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CANNULATED STRAIGHT DRIVER; SHOULDER, INSTRUMENTS
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ZIMMER BIOMET, INC. CANNULATED STRAIGHT DRIVER; SHOULDER, INSTRUMENTS Back to Search Results
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.
 
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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 Key8519272
MDR Text Key142120277
Report Number0001822565-2019-01554
Device Sequence Number1
Product Code KWT
Combination Product (y/n)N
PMA/PMN Number
K103404
Number of Events Reported1
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
Date FDA Received04/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number00430707400
Device Lot Number62356352
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/09/2019
Was the Report Sent to FDA? No
Date Manufacturer Received06/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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