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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MODULAR CAPTURE - DISTAL RESECTION INSTRUMENT

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STRYKER ORTHOPAEDICS-MAHWAH MODULAR CAPTURE - DISTAL RESECTION INSTRUMENT Back to Search Results
Catalog Number 6541-1-723
Device Problem Product Quality Problem (1506)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/28/2015
Event Type  Malfunction  
Event Description

The customer, (b)(6), has reported that whilst inspecting their distal caprure assembly devices as part of ra 2014-169, they have found a non conforming device as detailed in the inspection bulletin.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies. The complaint history review indicated that there have been similar events for the reported lot. Visual inspection on the returned device identified a fracture weld on one of the pins. A capa determined root cause as: in-process manufacturing tolerance change made at supplier location without formal change control process and adequate assessment of deliverables to be implemented. Notification to stryker also missed due to lack of change control.

 
Event Description

The customer, (b)(6), has reported that whilst inspecting their distal caprure assembly devices as part of ra 2014-169, they have found a non conforming device as detailed in the inspection bulletin.

 
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Brand NameMODULAR CAPTURE - DISTAL RESECTION
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 Key4795373
MDR Text Key5829250
Report Number0002249697-2015-01678
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberK123486
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 04/28/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/26/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number6541-1-723
Device LOT NumberER6ED9
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/14/2015
Is The Reporter A Health Professional? Yes
Date Manufacturer Received06/08/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/07/2011
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction Number2249697-3/20/2015-004R

Patient TREATMENT DATA
Date Received: 05/26/2015 Patient Sequence Number: 1
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