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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONFORMIS, INC. TIBIAL INSERT IMPACTOR TIP; REUSABLE IMPACTOR COMPONENT
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CONFORMIS, INC. TIBIAL INSERT IMPACTOR TIP; REUSABLE IMPACTOR COMPONENT Back to Search Results
Catalog Number ED-03475
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/01/2018
Event Type  malfunction  
Manufacturer Narrative
It was reported that the tibial insert impactor tip broke during surgery.The surgery was competed successfully.Review of the device history record indicates that the device was manufactured to specification.
 
Event Description
It was reported that the tibial insert impactor tip broke during surgery.The surgery was competed successfully.
 
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Brand Name
TIBIAL INSERT IMPACTOR TIP
Type of Device
REUSABLE IMPACTOR COMPONENT
Manufacturer (Section D)
CONFORMIS, INC.
600 technology park drive
billerica MA 01821
Manufacturer (Section G)
CONFORMIS, INC.
600 research drive
wilmington MA 01887
Manufacturer Contact
thomas haueter
600 technology park drive
billerica, MA 01821
7813459161
MDR Report Key7697980
MDR Text Key114333543
Report Number3004153240-2018-00168
Device Sequence Number1
Product Code OOG
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K161366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 07/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberED-03475
Device Lot NumberJ160101
Was Device Available for Evaluation? No
Date Manufacturer Received07/06/2018
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 Unknown
Patient Sequence Number1
Patient Age73 YR
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