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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET SPINE - BROOMFIELD 22MM SOLITAIRE U-JOINT AWL

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BIOMET SPINE - BROOMFIELD 22MM SOLITAIRE U-JOINT AWL Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/12/2016
Event Type  Injury  
Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted. Current information is insufficient to permit a valid conclusion about the cause of this event. If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

 
Event Description

The sales associate reported the u-joint awl instrument broke. During surgery, the tip of the awl snapped off while using the mallet. The tip was removed and discarded. The surgery was completed using another u-joint awl.

 
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Brand Name22MM SOLITAIRE U-JOINT AWL
Type of DeviceU-JOINT AWL
Manufacturer (Section D)
BIOMET SPINE - BROOMFIELD
310 interlocken parkway
suite 120
broomfield CO 80021
Manufacturer (Section G)
BIOMET SPINE - BROOMFIELD
310 interlocken parkway
suite 120
broomfield CO 80021
Manufacturer Contact
michelle cole
310 interlocken parkway
suite 120
broomfield, CO 80021
3034437500
MDR Report Key5857665
MDR Text Key51507775
Report Number3004485144-2016-00178
Device Sequence Number1
Product Code HWJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial
Report Date 07/12/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/09/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue NumberNSMD001165
Device LOT NumberUNKNOWN
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 08/09/2016 Patient Sequence Number: 1
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