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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TIBIAL ANKLE CLAMP ASSEMBLY INSTRUMENT

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STRYKER ORTHOPAEDICS-MAHWAH TIBIAL ANKLE CLAMP ASSEMBLY INSTRUMENT Back to Search Results
Catalog Number 8000-1040
Device Problems Clamp (757); Failure to Cut (2587); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/05/2015
Event Type  Malfunction  
Event Description

Operative assistant reported the following event for dr (b)(6). , implant surgeon: "during the implantation of triathlon pkr where i was present to assist the surgeon, it was not possible to carry out the tibial cut with the ankle clamp system. The ankle clamp system was not adapted to the patient, the minimum setting was too high, the attachment of the proximal shaft arm was not in contact with the tibial eminence. Impossible for the surgeon to perform the distal tibial cut with instrumentation sent. Another instrumentation kit was opened to use another device. There was a delay of about 15 minutes, but the procedure was successfully completed. No impact for the patient. ".

 
Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

 
Manufacturer Narrative

Based on the provided information, the product reported in this investigation did not contribute to the event. The scorpio clamp reported in this event did not contribute to any failure as the ankle clamp does not interfere with the high of the attachment in this case the proximal rod. There is no indication that the product reported in this investigation may have contributed to the event. No further investigation is required at this time. If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

 
Event Description

Operative assistant reported the following event for dr (b)(6), implant surgeon: "during the implantation of triathlon pkr where i was present to assist the surgeon, it was not possible to carry out the tibial cut with the ankle clamp system. The ankle clamp system was not adapted to the patient, the minimum setting was too high, the attachment of the proximal shaft arm was not in contact with the tibial eminence. Impossible for the surgeon to perform the distal tibial cut with instrumentation sent. Another instrumentation kit was opened to use another device. There was a delay of about 15 minutes, but the procedure was successfully completed. No impact for the patient. ".

 
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Brand NameTIBIAL ANKLE CLAMP ASSEMBLY
Type of DeviceINSTRUMENT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
william hanna
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key4638500
MDR Text Key5757347
Report Number0002249697-2015-00949
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK123486
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,HEALTH PROFESSIONAL,OTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/05/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/27/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number8000-1040
Device LOT NumberRD6V076
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/25/2015
Was Device Evaluated By Manufacturer? No
Date Device Manufactured02/10/2012
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 03/27/2015 Patient Sequence Number: 1
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