MAUDE Adverse Event Report: MEDLINE RENEWAL MEDLINE RENEWAL REPROCESSED SCORPION NEEDLE; SUTURE PASSER

Model Number AR-13991N

Device Problem Material Fragmentation (1261)

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

Event Date 10/13/2016

Event Type  malfunction  

Manufacturer Narrative

The device in question was returned to medline renewal for evaluation.Upon receipt, medline renewal confirmed the device had been reprocessed.Our evaluation confirmed the report, however the tip was not returned for evaluation.Our investigation included both an inspection of the returned device, and a review of the device history record (dhr).We reconfirmed that all processes were conducted as required, and that the device met inspection and requirements prior to packaging and release.Unfortunately, the root cause of the device failure is unknown at this time.Per the device instructions for use (ifu), the use of excessive force to pass the needle through fibrous/calcific tissue, or striking bone can cause needle breakage and patient injury.This can be avoided by repositioning the needle pass through a different area.There has been no report of adverse patient consequence as a result of the incident.However, due to the surgical intervention to retrieve the tip which caused a delay in the procedure, medline renewal is filing this medwatch report.

Event Description

Medline renewal received a report indicating that the tip of a reprocessed arthrex surefire scorpion needle, model ar-13991n, detached during use.The tip was retrieved by the surgeon.Another device was readily available to complete the procedure; therefore no patient harm or additional medical intervention was reported as a result of the incident.

• Brand Name: MEDLINE RENEWAL REPROCESSED SCORPION NEEDLE
• Type of Device: SUTURE PASSER
• 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: 6102890
• MDR Text Key: 59903386
• Report Number: 3032391-2016-00042
• Device Sequence Number: 1
• Product Code: HWQ
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 11/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/31/2019
• Device Model Number: AR-13991N
• Device Lot Number: 312381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2016
• 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
• Patient Age: 44 YR