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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PRECISION FALCON OSCILLATING TIP SAW CARTRIDGE (25 X 1.27 X 90MM); INSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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STRYKER INSTRUMENTS-KALAMAZOO PRECISION FALCON OSCILLATING TIP SAW CARTRIDGE (25 X 1.27 X 90MM); INSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Catalog Number 6725127090
Device Problem Break (1069)
Patient Problem Radiation Exposure, Unintended (3164)
Event Date 08/30/2016
Event Type  malfunction  
Manufacturer Narrative
The device is available for return.A follow up report will be filed once the quality investigation is complete.Awaiting device return to manufacturer.
 
Event Description
It was reported that during a high tibial osteotomy procedure, the blade broke at the cutting end.It was also reported that the broken piece was removed using an arthroscope and curette and washout, which resulted in a 10 minute delay.It was further reported that an additional x-ray was required to confirm the broken piece was removed from the patient.It was also reported that the procedure was completed successfully.
 
Manufacturer Narrative
The concomitant handpiece initially reported was 7209000000e, sn (b)(4), the actual concomitant handpiece for this event is 7209009000, sn (b)(4).
 
Event Description
It was reported that during a high tibial osteotomy procedure, the blade broke at the cutting end.It was also reported that the broken piece was removed using an arthroscope and curette and washout, which resulted in a 10 minute delay.It was further reported that an additional x-ray was required to confirm the broken piece was removed from the patient.It was also reported that the procedure was completed successfully.
 
Manufacturer Narrative
The blade involved with this event was returned for evaluation and the reported failure of blade breakage was confirmed on receipt of the blade.Investigation results indicate that the blade teeth had wear and impact marks consistent with metal contact.The ifu for the associated handpiece (7209-009-700 rev c) states "the stryker precision system is intended for use in the cutting and shaping of bone and other bone related tissue.".
 
Event Description
It was reported that during a high tibial osteotomy procedure, the blade broke at the cutting end.It was also reported that the broken piece was removed using an arthroscope and curette and washout, which resulted in a 10 minute delay.It was further reported that an additional x-ray was required to confirm the broken piece was removed from the patient.It was also reported that the procedure was completed successfully.
 
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Brand Name
PRECISION FALCON OSCILLATING TIP SAW CARTRIDGE (25 X 1.27 X 90MM)
Type of Device
INSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-IRELAND
instruments division
carrigtwohill bus. & tech park
carrigtwohill NA
Manufacturer Contact
dervillia murphy
instruments division
carrigtwohill bus. & tech park
carrigtwohill NA
214532900
MDR Report Key5978637
MDR Text Key55667736
Report Number0001811755-2016-02384
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Nurse
Type of Report Initial,Followup,Followup
Report Date 08/30/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/26/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/01/2021
Device Catalogue Number6725127090
Device Lot Number16134017
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/27/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/10/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/13/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
(B)(4)
Patient Outcome(s) Other;
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