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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 1-3 KEEL PUNCH INSTRUMENT

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STRYKER ORTHOPAEDICS-MAHWAH SIZE 1-3 KEEL PUNCH INSTRUMENT Back to Search Results
Catalog Number 6541-2-013
Device Problems Break (1069); Defective Device (2588); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Date 05/27/2015
Event Type  Malfunction  
Event Description

It was reported that the breakage of the keel punch was noticed before the medical procedure. So, spare product was used instead of it in the medical procedure.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

An event regarding a dissociated dowel pin from a triathlon keel punch was reported. The event was confirmed. Method & results: -device evaluation and results: a visual inspection confirmed the reported event. The dowel pin was returned dissociated from the device body. -medical records received and evaluation: not performed as patient factors did not contribute to the event. -device history review: all devices accepted into final goods conformed to specification. -complaint history review: there have been no similar previous reported events for this lot id. Conclusions: the investigation concluded that the dowel pin dissociating from the keel punch body was the result of a manufacturing nonconformance, where the keel punch body hole was oversized.

 
Event Description

It was reported that the breakage of the keel punch was noticed before the medical procedure. So, spare product was used instead of it in the medical procedure.

 
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Brand NameSIZE 1-3 KEEL PUNCH
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 Key4860481
MDR Text Key5846188
Report Number0002249697-2015-02015
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeJA
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 05/27/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/22/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number6541-2-013
Device LOT NumberRD6T042
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 Received09/23/2015
Was Device Evaluated By Manufacturer? No
Date Device Manufactured12/16/2011
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: 06/22/2015 Patient Sequence Number: 1
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