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U.S. Department of Health and Human Services


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Model Number 375-544-000
Device Problems Break (1069); Detachment Of Device Component (1104); Difficult to Remove (1528); Device Or Device Fragments Location Unknown (2590)
Patient Problems Fever (1858); Device Embedded In Tissue or Plaque (3165)
Event Date 11/15/2016
Event Type  Injury  
Manufacturer Narrative
The device was not returned to stryker sustainability solutions for evaluation. The device is currently being held by risk management. 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. Therefore, the most likely root cause is the user applying 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 manufacturer¿s 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 at that time. The reported event will continue to be monitored through post-market surveillance.
Event Description
It was reported the tip of the arthroscopic shaver broke off into the patient during the procedure. An attempt to remove the tip resulted in a 1. 5 hour delay in procedure. X-ray was used to identify the broken tip and additional anesthesia was required as a result of the delay. The tip was not able to be retrieved. The doctor will monitor the patient and bring her back if necessary, however no follow-up procedure is planned to remove the tip. The patient was stable during procedure and experienced a low fever the day after the procedure. These are commonly used devices that are readily available.
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Brand NameNA
Manufacturer (Section D)
5307 great oak drive
lakeland FL 33815
Manufacturer (Section G)
5307 great oak drive
lakeland FL 33815
Manufacturer Contact
moira barton varty
1810 w. drake drive
tempe, AZ 85283
MDR Report Key6167838
MDR Text Key62315492
Report Number0001056128-2016-00162
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/15/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/12/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/23/2019
Device Model Number375-544-000
Device Catalogue Number375-544-000RR
Device Lot Number4954314
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/15/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/23/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Reuse