MAUDE Adverse Event Report: MEDLINE RENEWAL MEDLINE RENEWAL REPROCESSED ARTHREX COOLCUT DISSECTOR-SMALL JOINT; ARTHROSCOPIC SHAVER

Model Number AR-7300DS

Device Problems Fire (1245); Sparking (2595)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/30/2015

Event Type  malfunction  

Manufacturer Narrative

One arthrex coolcut¿ dissector small joint (blue/blue) 3.0mm, part # ar-7300ds was returned for evaluation.It was confirmed that the shaver had been reprocessed two times by medline renewal.Upon receipt, the tip of the inner shaft was still lodged in the outer shaft of the shaver.During evaluation, discoloration on the outer shaft was observed.It appeared that the outer shaft of the device had been exposed to heat which may have caused the shaft to change colors.Severe scoring and metal flakes on the inner shaft of the shaver were also noted, which is most likely a result of actuation of the shaver outside of saline or irrigating solution.No other devices, such as the wand, that may have contributed to the incident were returned for evaluation.In addition to the device evaluation, our investigation included a review of the device history record.We reconfirmed that all processes were conducted as required, and that the device met all the inspection requirements prior to packaging and release.Medline renewal does not have enough information to determine the failure mode exactly, and cannot determine root cause of the incident at this time.This is the first and only report of this type of incident received by medline renewal, and it appears to have been an isolated incident.Per the ifu reprocessed arthroscopic shavers and burs in the warnings and precautions it states the following: "do not allow the rotating shaver or burr to touch another surgical instrument, as this can cause nicks, compromise its sharpness, or cause it to break.If contact occurs, inspect the tip before proceeding; and to prevent overheating, periodic irrigation of the instrument during clinical use is recommended." medline renewal performed a retrospective review of complaints and determined that this incident met the criteria for mdr reporting but was not filed within the required 30 day timeframe.Although no patient harm was reported, due to the lack of information, and the fact that intervention was indicated as a result of the incident, medline renewal is retrospectively filing this medwatch report in an abundance of caution.(b)(4).

Event Description

Medline renewal received a report that a reprocessed arthrex coolcut dissector-small joint, model ar-7300ds "sparked" and "caught fire" prior to beginning a procedure.The report stated that the machine, a wand, and the dissector were moved into isolation at the customer's location where a biomed could investigate the integrity of the machine.

• Brand Name: MEDLINE RENEWAL REPROCESSED ARTHREX COOLCUT DISSECTOR-SMALL JOINT
• Type of Device: ARTHROSCOPIC SHAVER
• Manufacturer (Section D): MEDLINE RENEWAL; 2747 sw 6th st.; redmond OR 97756
• Manufacturer (Section G): MEDLINE RENEWAL; 2747 sw 6th st.; redmond OR 97756
• Manufacturer Contact: brandi panteleon ; 2747 sw 6th st.; redmond, OR 97756 ; 5415164180
• MDR Report Key: 6088236
• MDR Text Key: 59450514
• Report Number: 3032391-2016-00023
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician Assistant
• Device Expiration Date: 06/30/2018
• Device Model Number: AR-7300DS
• Device Catalogue Number: AR-7300DS
• Device Lot Number: 231695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2016
• Date Manufacturer Received: 12/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2015
• 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
• Patient Outcome(s): Required Intervention