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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS, INC. N/A ARTHROSCOPE

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STRYKER SUSTAINABILITY SOLUTIONS, INC. N/A ARTHROSCOPE Back to Search Results
Model Number N/A
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/07/2017
Event Type  malfunction  
Event Description
The physician was performing a shoulder arthroscopy, during the procedure shaver head broke off in shoulder during use. Shaver retrieved by physician intact. On shaver packaging it states reprocessed by stryker solutions. Blade aggressive plus 40. Arthroscopic cutter was reprocessed by stryker sustainability solutions. Physician stated he has had the same event occur with previous reprocessed supplies and stated he does not want to use these items in any of his future surgical procedures. The tip of the cutter broke off in the patient's shoulder and was retrieved by physician. The patient was discharged same day from recovery without complications. Reevaluate use of certain reprocessed supplies with potential of breakage during use. Check with stryker sustainability solutions of the process and if it may cause weakening or alteration of material with reprocessing that could cause potential breakage during use.
 
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Brand NameN/A
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
STRYKER SUSTAINABILITY SOLUTIONS, INC.
5300 region ct.
lakeland FL 33815
MDR Report Key6676848
MDR Text Key78698163
Report Number6676848
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 06/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/29/2017
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/30/2020
Device Model NumberN/A
Device Catalogue Number375-544-000
Device Lot Number5564387
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/06/2017
Event Location Hospital
Date Report to Manufacturer06/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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