MAUDE Adverse Event Report: ARTHREX INC. SCORPION NEEDLE, HIP LENGTH; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number	AR-16991N
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.Device history record review revealed nothing relevant to this event.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported via facility submitted medwatch report (0733000000-2018-8012) that in (b)(6) 2018 (specific date not provided) the doctor was performing a hip arthroscopy on a patient.As he inserted the arthrex scorpion needle, he noted that the tip had broken off of the needle.Needle was removed and x-rays were obtained with c-arm.The needle tip was not visualized.
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.Device history record review revealed nothing relevant to this event.The failure mode could not be determined, but the broken needle point condition can be caused by consistently passing the needle through challenging tissue (thick or calcified) or hitting bone.The mating part (instrument) was not returned along with mdr device.Standard function test could not be performed.Confirmed the needle strip thickness and width dimensions to be within specification.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported via facility submitted medwatch report (0733000000-2018-8012) that in january 2018 (specific date not provided) the doctor was performing a hip arthroscopy on a patient.As he inserted the arthrex scorpion needle, he noted that the tip had broken off of the needle.Needle was removed and x-rays were obtained with c-arm.The needle tip was not visualized.

• Brand Name: SCORPION NEEDLE, HIP LENGTH
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7302194
• Report Number: 1220246-2018-00071
• Device Sequence Number: 1741401
• Product Code: MDM
• UDI-Device Identifier: 10888867189369
• UDI-Public: 10888867189369
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2021
• Device Catalogue Number: AR-16991N
• Device Lot Number: 10073092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/07/2018
• Supplement Date Received by Manufacturer: 02/07/2018
• Initial Report FDA Received Date: 02/28/2018
• Supplement Report FDA Received Date: 05/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other