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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MONOGRAM PATELLA CLAMP INSTRUMENT

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STRYKER ORTHOPAEDICS-MAHWAH MONOGRAM PATELLA CLAMP INSTRUMENT Back to Search Results
Catalog Number 6633-7-744
Device Problems Clamp (757); Break (1069); Insufficient Information (3190)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 10/21/2014
Event Type  Malfunction  
Event Description

(b)(4) stated: during total knee procedure, the patella clamp broke while in use. Instrument was removed from operative field, and given to materials coord. Xray taken, and reported as negative by radiology. Doctor aware of xray results. No harm to pt. Stryker rep also present at time of incident.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

Corrected data: the device was not returned for evaluation. The event could not be confirmed nor the root cause of the reported event determined due to the minimal information received. No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics. If devices and / or additional information become available, this investigation will be reopened. Not returned.

 
Event Description

User facility report # (b)(4). Stated: during total knee procedure, the patella clamp broke while in use. Instrument was removed from operative field, and given to materials coord. Xray taken, and reported as negative by radiology. Doctor aware of xray results. No harm to pt. Stryker rep also present at time of incident.

 
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Brand NameMONOGRAM PATELLA CLAMP
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
keyla navedo
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key4765160
MDR Text Key5777194
Report Number0002249697-2015-01493
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK123486
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User facility,OTHER,USER FACILITY
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 04/14/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/12/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number6633-7-744
Device LOT NumberUNKNOWN
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 Received09/23/2015
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 Reuse

Patient TREATMENT DATA
Date Received: 05/12/2015 Patient Sequence Number: 1
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