MAUDE Adverse Event Report: ARTHREX NEEDLE; SCORPION NEEDLE

Catalog Number AR-13995N

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/09/2017

Event Type  No Answer Provided  

Event Description

Scorpion needle was in use by surgeon.He hit the clavicle and the tip of the needle broke off.The surgeon made the call to not try to retrieve it.There were minimal risks for the pt with leaving the tip in.He would have had more damage retrieving it than leaving it.Dates of use: 1 hours.Diagnosis or reason for use: needle is used for rotator cuff repairs.

• Brand Name: NEEDLE
• Type of Device: SCORPION NEEDLE
• Manufacturer (Section D): ARTHREX
• MDR Report Key: 6646736
• MDR Text Key: 77864530
• Report Number: MW5070442
• Device Sequence Number: 1
• Product Code: GAB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/14/2017

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: AR-13995N
• Device Lot Number: 10085151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/14/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Weight: 95