MAUDE Adverse Event Report: ARTHREX, INC. IMPLANT SYSTEM, CPR MINI SCORPION DX; SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	IMPLANT SYSTEM, CPR MINI SCORPION DX
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/14/2021
Type of Reportable Event	Serious Injury
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 quickfix snap-off screws were difficult to snap off with the k-wire driver during a weil osteotomy procedure.The first screw (green 2x13 mm) was driven in with the k-wire and presented difficulty but did snap-off.The second screw (pink 2x11 mm) failed to snap-off when driven in with the k-wire driver.The k-wire driver was removed and a hand screwdriver was used to back out the screw a few turns then attempt re-insertion.When the screw head contacted the near-cortex, it still failed to snap-off.Additional force was applied manually in order to bend the wire insertion portion of the screw which caused cracking of the patient¿s bone.The surgery was completed by removing the screw manually, repositioning the osteotomy, manually inserting the screw with a.045 pilot hole, and manually snapping the screw off with a needle driver and hand driver.An additional.045 k-wire and #0 vicryl in a cerclage-like fashion were used for additional fixation.

• Brand Name: IMPLANT SYSTEM, CPR MINI SCORPION DX
• Common Device Name: SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11801459
• Report Number: 1220246-2021-03056
• Device Sequence Number: 14382974
• Product Code: GAT
• UDI-Device Identifier: 00888867044692
• UDI-Public: 00888867044692
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K122374
• 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): 05/10/2021

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: 09/30/2025
• Device Model Number: IMPLANT SYSTEM, CPR MINI SCORPION DX
• Device Catalogue Number: AR-8690DS
• Device Lot Number: 12002947
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 05/10/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other