MAUDE Adverse Event Report: MEDLINE RENEWAL MEDLINE RENEWAL REPROCESSED ARTHREX CRYSTAL CANNULA W/OBTURATOR; CANNULA, ORTHOPEDIC/ARTHROSCOPIC

Model Number AR-6560

Device Problems Material Fragmentation (1261); Material Integrity Problem (2978)

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

Event Date 05/06/2016

Event Type  malfunction  

Manufacturer Narrative

The device in question was returned to medline renewal for evaluation.One arthrex crystal cannula w/obturator, model ar-6560 was evaluated however the medline renewal package along with the original label was not returned with the device.We confirmed that the device had been reprocessed 2 times.During the investigation, it was confirmed that part of the cannula seal had detached from the housing, and it was the piece that the surgeon retrieved from the patient.Our investigation also included a review of the device history record, and we reconfirmed that all processes were conducted as required, and that the device met all the inspection requirements prior to packaging and release.The specific cause of the broken seal could not be determined.Medline renewal does not have enough information to determine the failure mode exactly, therefore, the root cause of the failure is unknown.However as a precaution, applicable production technicians were retrained on the visual inspection and acceptance requirements for this device.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, medical intervention was indicated as a result of the incident.Medline renewal is therefore retrospectively filing this medwatch report.

Event Description

Medline renewal received a report that the seal of a reprocessed arthrex crystal cannula w/obturator, model ar-6560, detached from the housing during use, and was retrieved by the surgeon during the procedure.

• Brand Name: MEDLINE RENEWAL REPROCESSED ARTHREX CRYSTAL CANNULA W/OBTURATOR
• Type of Device: CANNULA, ORTHOPEDIC/ARTHROSCOPIC
• 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: 6088141
• MDR Text Key: 59877368
• Report Number: 3032391-2016-00015
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• 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: AR-6560
• Device Catalogue Number: AR-6560
• Device Lot Number: 273553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2015
• 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