MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; ARTHROSCOPE

Model Number 375-544-000

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/29/2018

Event Type  Injury  

Manufacturer Narrative

The device evaluation is pending device return.A supplemental mdr will be submitted once the device evaluation is completed.The reported event will continue to be monitored through post-market surveillance.

Event Description

It was reported during a shoulder arthroscopy while the surgeon was using the 4mm arthroscopic shaver he felt it jam.When he removed it from the patient we noticed that the inner tip had broken off.The c-arm was used to try and locate the piece.They identified what appeared to be the tip and proceeded to attempt to retrieve it.However, due to its location, they were unable to remove it.These are commonly used devices that are readily available.

Manufacturer Narrative

The complaint device was returned to stryker sustainability solutions after the initial mdr was filed.The outer shaft of the device was not returned.The inner shaft of the device was returned.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 during a shoulder arthroscopy while the surgeon was using the 4mm arthroscopic shaver he felt it jam.When he removed it from the patient we noticed that the inner tip had broken off.The c-arm was used to try and locate the piece.They identified what appeared to be the tip and proceeded to attempt to retrieve it.However, due to its location, they were unable to remove it.These are commonly used devices that are readily available.

Manufacturer Narrative

On 11/18/2020, stryker sustainability solutions became aware that mdr section b2.(outcomes attributed to ae) was not completed for this mdr.This supplemental mdr serves to provide this information.The reported event will continue to be monitored through post market surveillance.

Event Description

It was reported during a shoulder arthroscopy while the surgeon was using the 4mm arthroscopic shaver he felt it jam.When he removed it from the patient we noticed that the inner tip had broken off.The c-arm was used to try and locate the piece.They identified what appeared to be the tip and proceeded to attempt to retrieve it.However, due to its location, they were unable to remove it.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
• MDR Report Key: 8195954
• MDR Text Key: 131391072
• Report Number: 0001056128-2018-00074
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00885825014247
• UDI-Public: 00885825014247
• Combination Product (y/n): N
• PMA/PMN Number: K012635
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2021
• Device Model Number: 375-544-000
• Device Catalogue Number: 375-544-000RR
• Device Lot Number: 9175800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Initial Date Manufacturer Received: 12/04/2018
• Initial Date FDA Received: 12/26/2018
• Supplement Dates Manufacturer Received: 01/09/2019; 11/18/2020
• Supplement Dates FDA Received: 01/21/2019; 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention