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

Model Number	AR-13997SF
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/25/2017
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.The device is expected for evaluation but has not yet been received.The cause of the event could not be determined from the information available and without device evaluation.Device history record revealed nothing relevant to this event.This is the first complaint of this type for this part/lot combination.The potential causes of this event are being communicated to the event reporter.If the device is returned and additional information is obtained, a follow-up report will be submitted.
Event or Problem Description
It was reported that during a shoulder arthroscopy case, after a few passes, the surgeon went to fire through the cuff and the fastpass scorpion would no longer fire.The front jaw had no resistance.A second scorpion was opened and used to complete the case with no adverse effect to the patient.After completion of the case, the rep observed the device and stated that it looked like the scorpion link was missing as the jaw just wobbled on the end.X-rays were not taken to confirm if the missing piece was not left in the patient.Follow up investigation: per the rep present for the case the scorpion trigger seems to be the issue.The link/spring in the trigger seems to be missing, making the jaw wobble.
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.This is a follow-up submission to reflect device evaluation.Complaint confirmed.The device met all material specifications as received.Broken nipple (s) on the finger were not returned along with complaint device.A precise cause for a broken nipple on the finger could not be determined.The mating part (needle) used in the event was not returned.Function test could not be performed.This is the first complaint of this type for this part/lot combination.The potential causes of this event are being communicated to the event reporter.
Event or Problem Description
It was reported that during a shoulder arthroscopy case, after a few passes, the surgeon went to fire through the cuff and the fastpass scorpion would no longer fire.The front jaw had no resistance.A second scorpion was opened and used to complete the case with no adverse effect to the patient.After completion of the case, the rep observed the device and stated that it looked like the scorpion link was missing as the jaw just wobbled on the end.X-rays were not taken to confirm if the missing piece was not left in the patient.Follow up investigation: per the rep present for the case the scorpion trigger seems to be the issue.The link/spring in the trigger seems to be missing, making the jaw wobble.

• Brand Name: FASTPASS SCORPION
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6872397
• Report Number: 1220246-2017-00339
• Device Sequence Number: 10904298
• Product Code: MDM
• UDI-Device Identifier: 00888867015982
• UDI-Public: 00888867015982
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2017

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
• Operator of Device: Health Professional
• Device Model Number: AR-13997SF
• Device Lot Number: 54304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2017
• Supplement Date Received by Manufacturer: 08/29/2017
• Initial Report FDA Received Date: 09/18/2017
• Supplement Report FDA Received Date: 10/05/2017
• 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