MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; ARTHROSCOPE

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.

• Brand Name: NA
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• Manufacturer (Section G): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• Manufacturer Contact: moira barton varty ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 6167838
• MDR Text Key: 62315492
• Report Number: 0001056128-2016-00162
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00885825014247
• UDI-Public: (01)00885825014247(17)190923(10)4954314
• 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: 11/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2019
• Device Model Number: 375-544-000
• Device Catalogue Number: 375-544-000RR
• Device Lot Number: 4954314
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2016
• 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