MAUDE Adverse Event Report: MEDLINE RENEWAL MEDLINE RENEWAL REPROCESSED ARTHROSCOPIC SHAVER

Model Number 375-562-000

Device Problems Use of Device Problem (1670); Material Deformation (2976)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Manufacturer Narrative

Medline renewal received a report that the tip of an arthroscopic shaver broke after just five seconds of use.An x-ray was performed during the procedure to confirm the location of the tip, however it could not be retrieved.A second shaver was used to complete the case.Both the inner and outer blade assembly components were returned to medline renewal for evaluation, and upon receipt, the initial device evaluation confirmed that the tip of the inner blade shaft was broken and missing.Further inspection determined that the inner blade had been reprocessed by medline renewal, but that the outer blade had not been reprocessed.Therefore, the complete reprocessed device in question was not returned for evaluation.Without the outer shaft, we are unable to draw a conclusion regarding the root cause of incident.As part of the reprocessing process, 100% of shavers and burs are visually inspected under a microscope multiple times to ensure that all acceptance criteria are met.As part of this investigation, medline renewal performed a review of the manufacturing documentation for lot 276124, and we reconfirmed that all processing parameters and inspection requirements were met prior to product release.This medwatch report was originally submitted on 02/16/2016, however due to an internal error, this report was submitted through the esg test account instead of the esg production account.Consequently, cdrh did not receive this report within the 30 day timeframe.Therefore, this medwatch report now reflects today's date which corresponds with the file transmission through the esg production account.

Event Description

Medline renewal received a report that the tip of an arthroscopic shaver broke after just five seconds of use.An x-ray was performed during the procedure to confirm the location of the tip, however, it could not be retrieved.A second shaver was used to complete the case.

• Brand Name: MEDLINE RENEWAL REPROCESSED ARTHROSCOPIC SHAVER
• 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: 6087909
• MDR Text Key: 59456097
• Report Number: 3032391-2016-00004
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012667
• 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
• Device Expiration Date: 12/31/2018
• Device Model Number: 375-562-000
• Device Catalogue Number: 375-562-000
• Device Lot Number: 276124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2015
• 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
• Patient Age: 75 YR
• Patient Weight: 102