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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. PLAIN BAR 96 IN. I.V. POST W/ CLAMP APPARATUS, TRACTION, NON-POWERED

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ZIMMER SURGICAL, INC. PLAIN BAR 96 IN. I.V. POST W/ CLAMP APPARATUS, TRACTION, NON-POWERED Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem Head Injury (1879)
Event Date 11/15/2016
Event Type  Injury  
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4). Review of the receiving inspection report could not be performed as no lot number was reported for this complaint. Product examination could not be performed as no product was returned for this complaint. However, the pictures provided by the customer do show damage to the clamp. This complaint is confirmed. The root cause of the reported event could not be specifically determined with the provided information. The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.
 
Event Description
It was reported that the hinge on the clamp cross bar cracked causing the bar to disengage from the frame and hit a patient on the forehead. Patient was sent for ct scan. No additional adverse consequences have been reported.
 
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Brand NamePLAIN BAR 96 IN. I.V. POST W/ CLAMP
Type of DeviceAPPARATUS, TRACTION, NON-POWERED
Manufacturer (Section D)
ZIMMER SURGICAL, INC.
200 west ohio avenue
dover OH 44622
Manufacturer (Section G)
ZIMMER SURGICAL, INC.
200 west ohio avenue
dover OH 44622
Manufacturer Contact
christina arnt
56 e. bell drive
warsaw, IN 46582
5745273773
MDR Report Key6802127
MDR Text Key82977433
Report Number0001526350-2017-00551
Device Sequence Number1
Product Code HST
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PPREAMEND
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,user facility
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 08/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number00123800100
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 08/17/2017 Patient Sequence Number: 1
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