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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; ARTHROSCOPE

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STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; ARTHROSCOPE Back to Search Results
Model Number 375-544-000
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/10/2016
Event Type  malfunction  
Manufacturer Narrative
The device was not returned to stryker sustainability solutions for evaluation.It was stated the broken shaver was inadvertently discarded after the case.As the device was not returned for evaluation, visual and functional inspection was unable to be performed.A review of the dhr for the reported lot number supports that the device met all inspection and test criteria prior to release from stryker.The reported event could be attributed to user applied too much force to the device or the arthroscopic shaver may have come into contact with staples, clips or another metal object, resulting in damage to the blade.The instructions for use (ifu) state: - before beginning the procedure, verify compatibility of all instruments and accessories.- plug in and set up the generator according to the instructions in the manufacturers¿ manual.- select an arthroscopic shaver with size, blade, and function most appropriate for the procedure.- inspect the instrument for overall condition and physical integrity.Do not use the instrument if any damage is noted.Return the instrument and packaging to stryker sustainability solutions if it is not in acceptable condition for surgery.- careful handling of the instrument is necessary to avoid damage or breakage as a result of excessive force.- do not apply excessive pressure or ¿side-load¿ the blade during use.Side-loading does not improve the performance of the instrument, can dull the blade, and/or produce metal particulates.- do not allow the arthroscopic shaver to come into contact with staples, clips or any metal object to avoid damage to the blade and possible patient injury.- the tip of the bur or cutter must be irrigated periodically (general recommendation: once a minute) to cool the blade and prevent excised tissues from accumulating.- do not run the instrument without appropriate suction for the duration of the process.Should the device become available for return, the investigation will be reopened.The reported event will continue to be monitored through post-market surveillance.(b)(4).
 
Event Description
It was reported the metal tip of the arthroscopic shaver broke inside the patient's shoulder.The doctor flushed out all debris, leading to a five minute delay in procedure.The broken shaver was replaced.There was no patient injury or medical intervention reported.These are commonly used devices that are readily available.
 
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Brand Name
NA
Type of Device
ARTHROSCOPE
Manufacturer (Section D)
STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
5307 great oak drive
lakeland FL 33815
Manufacturer (Section G)
STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
5307 great oak drive
lakeland FL 33815
Manufacturer Contact
moira barton varty
1810 w. drake drive
tempe, AZ 85283
8888883433
MDR Report Key6206493
MDR Text Key63658870
Report Number0001056128-2016-00166
Device Sequence Number1
Product Code HRX
UDI-Device Identifier00885825014247
UDI-Public(01)00885825014247(17)190616(10)4636103
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K012635
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Nurse
Type of Report Initial
Report Date 12/27/2016
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 Expiration Date06/16/2019
Device Model Number375-544-000
Device Catalogue Number375-544-000RR
Device Lot Number4636103
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/07/2016
Initial Date FDA Received12/27/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/16/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Reuse
Patient Sequence Number1
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