MAUDE Adverse Event Report: MEDLINE RENEWAL STRYKER; AR-13995N @MULTIFIRE SCORPION NDL (BLACK

Catalog Number AR13995NR

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

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

Event Date 02/15/2020

Event Type  malfunction  

Manufacturer Narrative

It was initially reported that the needle broke off into the patient.The needle was retrieved and oem was used.It was further mentioned that this event did not cause harm to the patient.Despite good faith efforts to obtain additional information, the reporting facility was unable or unwilling to provide any further patient, product, or procedural details.Due to the reported required medical intervention to retrieve the broken needle, this medwatch is filed.The sample has not been returned.A definitive root cause therefore could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported the needle broke off into patient.It was removed and oem used.

• Brand Name: STRYKER
• Type of Device: AR-13995N @MULTIFIRE SCORPION NDL (BLACK
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock ave; redmond, or
• Manufacturer Contact: teresa maynard ; three lakes drive; northfield, il ; 9311514
• MDR Report Key: 9853274
• MDR Text Key: 190748361
• Report Number: 3032391-2020-00003
• 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: 03/19/2020

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
• Device Catalogue Number: AR13995NR
• Device Lot Number: 423750
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/03/2020
• Initial Date FDA Received: 03/19/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention