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

Model Number AR-13995N

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2017

Event Type  Injury  

Manufacturer Narrative

Although multiple attempts were made to retrieve the device, it was not returned to for evaluation.Therefore we could not confirm if the device was reprocessed.Additionally, the lot number was not provided, therefore a review of the reprocessing records could not be performed.Due to the lack of information surrounding the incident, we do not have enough information to determine the root cause of the failure.If more information is provided then this mdr will be updated.There was no report of an adverse patient consequence or medical intervention as a result of the incident.However, in an abundance of caution, we are filing this medwatch report.Device not returned to manufacturer.

Event Description

We received a report indicating that the tip of a reprocessed arthrex multifire scorpion needle, model ar-13995n, detached during use.The physician was not able to retrieve the detached tip.

• Brand Name: REPROCESSED ARTHREX MULTIFIRE 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: 6349402
• MDR Text Key: 68031669
• Report Number: 3032391-2017-00003
• 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: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: AR-13995N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/23/2017
• Initial Date FDA Received: 02/22/2017
• 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