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

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.

• Brand Name: N/A
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 5300 region ct.; lakeland FL 33815
• MDR Report Key: 6676848
• MDR Text Key: 78698163
• Report Number: 6676848
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Expiration Date: 01/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 375-544-000
• Device Lot Number: 5564387
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/06/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 32 YR