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

Model Number AR-13991N

Device Problem Material Integrity Problem (2978)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 04/15/2016

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation, and the lot number of the failed device could not be determined.Therefore, medline renewal does not have enough information to determine the root cause of the failure.The instructions for use warn the user that the tip of the device may break if excessive force is applied, and that the use of force to pass the needle through fibrous/calcified tissue, or striking bone, can cause needle breakage and patient injury.It is recommended to reposition the needle to pass through a different area.Although the device was not returned for evaluation, medline renewal is filing this medwatch report in an abundance of caution.(b)(4).

Event Description

Medline renewal received a report that the tip of a reprocessed arthrex surefire scorpion needle detached during the course of surgery.It is not known if the tip of the needle was retrieved, however the report stated that the patient was not harmed.The device was not returned to medline renewal for evaluation.

• Brand Name: MEDLINE RENEWAL REPROCESSED ARTHREX SUREFIRE 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: 6088126
• MDR Text Key: 59456570
• Report Number: 3032391-2016-00007
• 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: 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: Physicist
• Device Model Number: AR-13991N
• Device Catalogue Number: AR-13991N
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/25/2016
• Initial Date FDA Received: 11/08/2016
• 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