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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SINGLE USE INSTRUMENTS - TIBIAL KIT (CR) - SIZE 2

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STRYKER ORTHOPAEDICS-MAHWAH SINGLE USE INSTRUMENTS - TIBIAL KIT (CR) - SIZE 2 Back to Search Results
Catalog Number 5555-2322
Device Problem Device Disinfection Or Sterilization Issue (2909)
Patient Problem No Information (3190)
Event Date 03/30/2015
Event Type  Malfunction  
Event Description

As the single use trial was being opened i noticed a hair inside the sterile packaging.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

An event regarding a hair in the inner sterile pack involving a single use instruments - tibial kit (cr) - size 2 was reported. The event was confirmed. Method and results: device evaluation and results: visual inspection confirmed a hair within the inner sterile pack. Medical records received and evaluation: not performed as it was reported that there were no adverse consequences nor medical intervention. Device history review: there were no reported discrepancies for the lot referenced. Complaint history review: there have been no other events for the lot referenced. Conclusions: the device was not made to specification as a foreign hair was packaged in the inner sterile blister pack with the device unintendedly. Nc was raised regarding the compromised packaging.

 
Event Description

As the single use trial was being opened i noticed a hair inside the sterile packaging.

 
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Brand NameSINGLE USE INSTRUMENTS - TIBIAL KIT (CR) - SIZE 2
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
beverly lima
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key4719429
MDR Text Key18545323
Report Number0002249697-2015-01332
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK132624
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/30/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/22/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5555-2322
Device LOT Number30061401
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/13/2015
Is The Reporter A Health Professional? Yes
Date Manufacturer Received06/02/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/22/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/22/2015 Patient Sequence Number: 1
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