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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 4-6 KEEL PUNCH; INSTRUMENT
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STRYKER ORTHOPAEDICS-MAHWAH SIZE 4-6 KEEL PUNCH; INSTRUMENT Back to Search Results
Catalog Number 6541-2-046
Device Problems Defective Component (2292); Failure to Advance (2524)
Patient Problem No Code Available (3191)
Event Date 02/06/2015
Event Type  malfunction  
Event Description
The sales rep has reported that the keel punch is allegedly unable to be used for its designed purpose as it is prevented from passing through the keel tower housing by a reported fault on the punch.The sales rep has reported that this event has not caused any issue regarding a patients treatment or outcome.Updated information stated that the sales rep has reported that there was a 5 minute delay to surgery as a result of the reported event.The surgery was successfully completed by using an available alternative instrument.The sales rep has reported that as the surgeon was preparing the tibial base plate for a triathlon knee, it was noted that the keel punch would not advance through the keel punch tower due to the defect.
 
Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Device not available at this time.
 
Manufacturer Narrative
An event regarding a dowel pin disassociating from a size 4-6 keel punch was reported.The event was confirmed.Method and results: the provided photographs showed the keel punch impaction & extraction lever to be assembled incorrectly leaving the guide backwards; this generates not been able to slide with the matting component keel punch guide as intended.The returned device confirmed the event.Review of the device history records indicates that all devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicates there has been (b)(4) other events for the lot referenced.Conclusions: the investigation concluded that the dowel pin coming out of the keel punch body was caused by a manufacturing nonconformance.Based upon the conclusions of the visual analysis from the provided photographs showed the keel punch impaction and extraction lever to be assembled incorrectly, most likely which the dowel pin come out of the assembly and was put together probably at the cleaning and sterilization reprocessing handling, as the device has been in used from (b)(6) 2011 to the reported date of (b)(6) 2015.It was concluded that the supplier, (b)(4), had oversized the keel punch body hole and not fulfilled the press fit operation which led to the dowel pin coming out of the assembly.Stryker reserves the right to re-evaluate this investigation if additional relevant information becomes available.Root cause investigation concluded there is a faulty check valve.Corrections were performed as part of capa.
 
Event Description
The sales rep has reported that the keel punch is allegedly unable to be used for its designed purpose as it is prevented from passing through the keel tower housing by a reported fault on the punch.The sales rep has reported that this event has not caused any issue regarding a patients treatment or outcome.Updated information stated that the sales rep has reported that there was a 5 minute delay to surgery as a result of the reported event.The surgery was successfully completed by using an available alternative instrument.The sales rep has reported that as the surgeon was preparing the tibial base plate for a triathlon knee, it was noted that the keel punch would not advance through the keel punch tower due to the defect.
 
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Brand Name
SIZE 4-6 KEEL PUNCH
Type of Device
INSTRUMENT
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 Key4552939
MDR Text Key5523344
Report Number0002249697-2015-00498
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K123486
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/06/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number6541-2-046
Device Lot NumberRD6A082
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/27/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/19/2015
Initial Date FDA Received02/27/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received07/15/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/03/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age72 YR
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