MAUDE Adverse Event Report: ARTHREX, INC. EASY-OUT, MICRO COMPRESSION FT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	EASY-OUT, MICRO COMPRESSION FT
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/22/2021
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
On 11/24/2021, it was reported by a sales representative via e-mail that a ar-8737-37 shaft tip broke off, and a ar-8737-61 screw remover tip broke.This occurred on (b)(6) 2021 during a metacarpal fracture while inserting the 2.5mmx50mm into the 4th metacarpal the canal of the metacarpal it was very tight.The metacarpal was prepared with the correct corresponding drill bit for the 2.5mm headless compression ft screw.While inserting the screw the cannulated screw driver tip (ar-8737-37) broke off and was then removed.The surgeon then proceeded to use the solid screw driver in the set to continue inserting the screw.The screw became tight in the shaft of the 4th metacarpal and of the approximately 4mm of the screw broke.The headless, broken portion of the screw was removed.The surgeon continue using the corresponding easy out (ar-8737-61) to try and remove the portion of the screw that was still in the 4th metacarpal, and the easy out tip broke upon trying to remove the screw and the small portion of the tip was left inside of the cannulated portion of the screw.The screw was left in the 4th metacarpal as compression across the fracture site was achieved.The screw remains in the patient.
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
On 11/24/2021, it was reported by a sales representative via e-mail that a ar-8737-37 shaft tip broke off, and a ar-8737-61 screw remover tip broke.This occurred on (b)(6) 2021 during a metacarpal fracture while inserting the 2.5mmx50mm into the 4th metacarpal the canal of the metacarpal it was very tight.The metacarpal was prepared with the correct corresponding drill bit for the 2.5mm headless compression ft screw.While inserting the screw the cannulated screw driver tip (ar-8737-37) broke off and was then removed.The surgeon then proceeded to use the solid screw driver in the set to continue inserting the screw.The screw became tight in the shaft of the 4th metacarpal and of the approximately 4mm of the screw broke.The headless, broken portion of the screw was removed.The surgeon continue using the corresponding easy out (ar-8737-61) to try and remove the portion of the screw that was still in the 4th metacarpal, and the easy out tip broke upon trying to remove the screw and the small portion of the tip was left inside of the cannulated portion of the screw.The screw was left in the 4th metacarpal as compression across the fracture site was achieved.The screw remains in the patient.

• Brand Name: EASY-OUT, MICRO COMPRESSION FT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 12984855
• Report Number: 1220246-2021-04110
• Device Sequence Number: 19250910
• Product Code: LXH
• UDI-Device Identifier: 00888867263802
• UDI-Public: 00888867263802
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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
• Report Date (Section B): 12/13/2021

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: EASY-OUT, MICRO COMPRESSION FT
• Device Catalogue Number: AR-8737-61
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 12/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown