MAUDE Adverse Event Report: MEDLINE RENEWAL MEDLINE RENEWAL REPROCESSED REPROCESSED SMITH & NEPHEW CLEAR-TRAC CANNULA; ORTHOPEDIC TROCAR/CANNULA

Model Number 72200903

Device Problems Break (1069); Material Integrity Problem (2978)

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

Event Date 02/19/2016

Event Type  malfunction  

Manufacturer Narrative

Both devices were returned for evaluation, and the incidents were confirmed.Both devices were broken upon receipt, as reported.As part of the reprocessing process, 100% of the devices are visually inspected for cracks, and the distal tip is inspected for chipping per medline renewal's internal inspection procedure.Internal protocols also ensure that obturators can be fully inserted into and retracted from the cannula.Devices that do not meet acceptance criteria are rejected.In addition to the device evaluations, our investigation also 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 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 retrospectively filing this medwatch report in an abundance of caution.(b)(4).

Event Description

Medline renewal received a report that two identical reprocessed smith & nephew clear-trac complete threaded cannulas from the same lot number broke during use.The cannula top/cap broke off of one, and the side port broke off the other.The procedure was completed by replacing the broken devices with additional unused, reprocessed devices.No patient harm was reported as a result of these incidents.

• Brand Name: MEDLINE RENEWAL REPROCESSED REPROCESSED SMITH & NEPHEW CLEAR-TRAC CANNULA
• Type of Device: ORTHOPEDIC TROCAR/CANNULA
• 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: 6088144
• MDR Text Key: 59456143
• Report Number: 3032391-2016-00020
• 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: 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/31/2018
• Device Model Number: 72200903
• Device Catalogue Number: 72200903
• Device Lot Number: 282152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/23/2016
• Initial Date FDA Received: 11/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2016
• 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
• Patient Outcome(s): Required Intervention