MAUDE Adverse Event Report: MEDLINE RENEWAL ARTHREX; MULTIFIRE SCORPION NEEDLE (BLACK) OR (DARK GREY)

Catalog Number AR13995NR

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2018

Event Type  malfunction  

Manufacturer Narrative

It was reported that the reprocessed arthrex scorpion needle's tip broke off inside of the patient during a rotator cuff surgery.Per report, the broken tip was successfully retrieved from the surgical site through an unidentified method.There was no report of prolonged anesthesia, a serious injury or another adverse patient event at this time.Another device was obtained and the procedure was successfully completed.Due to the reported incident and in an abundance of caution, this medwatch is being filed.The sample is not available to be returned for evaluation.The lot number associated with the device was not reported.A review of the reprocessing record could not be performed.If additional relevant information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that the reprocessed arthrex scorpion needle's tip broke off inside of the patient.The broken tip was successfully retrieved from the surgical site.

• Brand Name: ARTHREX
• Type of Device: MULTIFIRE SCORPION NEEDLE (BLACK) OR (DARK GREY)
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock ave; redmond OR 97756
• Manufacturer Contact: stephen wilson ; 1500 ne hemlock ave; redmond, OR 97756
• MDR Report Key: 8080743
• MDR Text Key: 128290358
• Report Number: 3032391-2018-00020
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/16/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: AR13995NR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/14/2018
• Initial Date FDA Received: 11/16/2018
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 54 YR