MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; ARTHROSCOPE

Model Number	375-545-000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.Visual inspection revealed the inner and outer shafts did detach readily and there was not any obvious bend in the outer shaft.Some galling was observed along the inside diameter of the outer shaft and some cutting surface damage, which would indicate these areas may have experienced friction or metal-to-metal contact during clinical use.There was some visual evidence of clinical debris.The broken inner shaft tip showed tooth damage.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 causes are the 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.Follow a suitable surgery protocol.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.The reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported the arthroscopic shaver broke off into multiple pieces during surgery.The pieces were retrieved and removed.Additional anesthesia was administered.It is unknown by the facility how much, however, patient was in stable condition.There was no larger incision made and it is unknown by the facility if x-ray was done.Device was replaced to successfully complete the procedure.There was no patient injury or medical intervention and extended procedure time reported was 45 minutes to retrieve pieces.These are commonly used devices that are readily available.

• Brand Name: NA
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• MDR Report Key: 7724893
• Report Number: 0001056128-2018-00048
• Device Sequence Number: 13636499
• Product Code: HRX
• UDI-Device Identifier: 00885825014223
• UDI-Public: 00885825014223
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K012635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/26/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/03/2021
• Device Model Number: 375-545-000
• Device Catalogue Number: 375-545-000RR
• Device Lot Number: 8231445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2018
• Initial Report FDA Received Date: 07/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1