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	Insufficient Information (4580)
Date of Event	04/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 4/11/2022, it was reported by a distributor via email that an ar-8690ds pr mini scorpion, dx and micro suturelasso implant system had a couple of issue.The micro suturelasso cannulation would not allow the nitinol wire to be passed and the dx mini scorpion needle broke during use, all broken fragments were retrieved.Surgeon opened another ar-8690ds kit, and the micro suturelasso also did not allow the nitinol wire to pass through.This was discovered during a cpr, complete planter plate repair, procedure on (b)(6) 2022.Case was completed successfully and no further has been reported.
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.

• 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
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 14269407
• Report Number: 1220246-2022-04815
• Device Sequence Number: 5158855
• Product Code: GAT
• UDI-Device Identifier: 00888867044692
• UDI-Public: 00888867044692
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/02/2022

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: IMPLANT SYSTEM, CPR MINI SCORPION DX
• Device Catalogue Number: AR-8690DS
• Device Lot Number: 14936814
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 05/03/2022
• Date Device Manufactured: 03/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown