MAUDE Adverse Event Report: MEDLINE RENEWAL; AR-13991N @SUREFIRE SCORPION NDL

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that the tip of the scorpion needle broke off during a shoulder rotator cuff repair and fell into the surgical site.According to the reporting facility, the entirety of the broken scorpion needle tip was able to be retrieved from the surgical site using an arthroscopy grasper.No further incident was reported.The patient was under general anesthesia at the time of the incident and no additional anesthesia was required to complete the surgery.No adverse patient impact or follow-up care occurred.The device involved in the incident was reportedly discarded and no sample was available to be returned for evaluation.A root cause for the reported incident was unable to be determined at this time.Due to the reported need for medical intervention to retrieve the broke scorpion needle tip from the surgical site, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that the tip of the scorpion needle broke off during use.

• Type of Device: AR-13991N @SUREFIRE SCORPION NDL
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock avenue; redmond OR 97756 1876
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 11064466
• MDR Text Key: 230116355
• Report Number: 3032391-2020-00014
• Device Sequence Number: 1
• Product Code: HWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/23/2020

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: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/17/2020
• Initial Date FDA Received: 12/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention