MAUDE Adverse Event Report: ARTHREX, INC. CAPSULECLOSE SCORPION; PLATE, FIXATION, BONE

Model Number	CAPSULECLOSE SCORPION
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that the tip of the ar-16992 scorpion broke off.The sales rep reported the case was completed without incident.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-16992, batch 10359098 capsuleclose scorpion was received for investigation.Visual inspection identified that the 118-204 shear pin, 910-019 suture clip, and the 910-021 suture clip spring components had broken off of the distal tip of the scorpion.The fragments generated during this event were not returned for analysis.Functional testing revealed that squeezing the finger allowed the tissue clamp assembly to advance as intended, although usability was impeded by the lack of tip components present.The observed condition is most likely the result of breakage at the shear pin as a result of dropping the device or smashing the device into solid material.

• Brand Name: CAPSULECLOSE SCORPION
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11872417
• Report Number: 1220246-2021-03164
• Device Sequence Number: 1374640
• Product Code: LXH
• UDI-Device Identifier: 00888867212688
• UDI-Public: 00888867212688
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2021

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
• Operator of Device: Health Professional
• Device Model Number: CAPSULECLOSE SCORPION
• Device Catalogue Number: AR-16992
• Device Lot Number: 10359098
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 08/02/2021
• Patient Sequence Number: 1