MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; ARTHROSCOPE

Model Number 375-545-000

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2018

Event Type  malfunction  

Manufacturer Narrative

The device was returned to stryker sustainability solutions for evaluation.Visual inspection revealed the inner shaft tip was completely detached from the shaft.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 Description

It was reported the arthroscopic shaver tip broke off inside the patient.The piece was successfully retrieved and did not require larger incision.There was no patient injury or medical intervention and extended procedure time reported was minimal to replace device.These are commonly used devices that are readily available.

• Brand Name: NA
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5300 region ct; lakeland FL 33815
• Manufacturer (Section G): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5300 region ct; lakeland FL 33815
• Manufacturer Contact: marissa richmond ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 8169669
• MDR Text Key: 131767180
• Report Number: 0001056128-2018-00072
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00885825014223
• UDI-Public: 00885825014223
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012635
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2021
• Device Model Number: 375-545-000
• Device Catalogue Number: 375-545-000RR
• Device Lot Number: 8544310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1