MAUDE Adverse Event Report: MEDLINE RENEWAL MEDLINE RENEWAL REPROCESSED DYONICS ARTHROSCOPIC SHAVER; ARTHROSCOPIC ACCESSORY

Model Number 72203013

Device Problem Material Integrity Problem (2978)

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

Event Date 04/05/2016

Event Type  malfunction  

Manufacturer Narrative

The device in question was not returned to medline renewal for evaluation, and no additional information was available at the time of the report and investigation.However, unused inventory of similar devices was returned to medline renewal as part of the complaint investigation.Review of the unused inventory confirmed the possibility of the reported device failure.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, intervention may have been required to complete the procedure, therefore, medline renewal is retrospectively filing this medwatch report.(b)(4).

Event Description

It was reported that a reprocessed dyonics platinum arthroscopic shaver snapped apart in the knee during use.The report did not indicate that the device failure resulted in patient harm.

• Brand Name: MEDLINE RENEWAL REPROCESSED DYONICS ARTHROSCOPIC SHAVER
• Type of Device: ARTHROSCOPIC ACCESSORY
• 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: 6088142
• MDR Text Key: 59461022
• Report Number: 3032391-2016-00016
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10888277354692
• UDI-Public: 10888277354692
• 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: health professional,user faci
• Reporter Occupation: Nurse
• 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 Model Number: 72203013
• Device Catalogue Number: 72203013
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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