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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CANN DRIVER BIT HEX 1.5MM AO TRAUMA, INSTRUMENT

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ZIMMER BIOMET, INC. CANN DRIVER BIT HEX 1.5MM AO TRAUMA, INSTRUMENT Back to Search Results
Model Number N/A
Device Problem Misassembled (1398)
Patient Problem No Code Available (3191)
Event Date 01/16/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products: unknown screw. Report source foreign-(b)(6). The customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. Product not returned.

 
Event Description

It was reported that during surgery, the screwdriver did not sit adequately tight in the screw. As a result, the screw could not be completely inserted. A delay of 30 minutes was reported as a result of this event. No additional patient consequences were reported. Attempts have been made and additional information on the reported event is unavailable at this time.

 
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Brand NameCANN DRIVER BIT HEX 1.5MM AO
Type of DeviceTRAUMA, INSTRUMENT
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key8275056
MDR Text Key134017206
Report Number0001825034-2019-00323
Device Sequence Number1
Product Code HSN
Combination Product (Y/N)N
PMA/PMN NumberK120906
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/23/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/24/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number231201225
Device LOT Number00080
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/04/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/22/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/29/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 01/24/2019 Patient Sequence Number: 1
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