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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC OPTETRAK RBK PS, HI-FLEX TIBIAL INSERT; RBK TIBIAL INSERT
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EXACTECH, INC OPTETRAK RBK PS, HI-FLEX TIBIAL INSERT; RBK TIBIAL INSERT Back to Search Results
Catalog Number 264-22-11
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem No Code Available (3191)
Event Date 09/06/2016
Event Type  Injury  
Manufacturer Narrative
The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation.Additonally, device specific information was not provided, precluding a review of the device history record.
 
Event Description
Index surgery: (b)(6) 2000.Revision of optetrak components due to loosening.This event occurred outside of the us in (b)(6), and was discovered as part of active surveillance.
 
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Brand Name
OPTETRAK RBK PS, HI-FLEX TIBIAL INSERT
Type of Device
RBK TIBIAL INSERT
Manufacturer (Section D)
EXACTECH, INC
2320 nw 66th ct
gainesville FL 32653
Manufacturer (Section G)
EXACTECH, INC
2320 nw 66th ct
gainesville FL 32653
Manufacturer Contact
graham cuthbert
2320 nw 66th ct
gainesville, FL 32653
3523771140
MDR Report Key6100487
MDR Text Key59835810
Report Number1038671-2016-00787
Device Sequence Number1
Product Code JWH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 11/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Catalogue Number264-22-11
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/10/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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