MAUDE Adverse Event Report: ARTHREX, INC. DELTOID LIGAMENT RECONST IMPLANT SYSTEM; SCREW, FIXATION, BONE

Model Number	DELTOID LIGAMENT RECONST IMPLANT SYSTEM
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/04/2019
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.
Event or Problem Description
It was reported during a deltoid ligament reconstruction procedure the ar-8918cp deltoid ligament reconstruction implant system was being used.Upon inserting the first 4.75 anchor within the kit into the talus, the anchor came apart and broke into multiple pieces.The surgeon decided not to use the remaining anchors within the ar-8918cp.The surgeon then used peek tenodesis screws to complete the procedure.The rep reported the surgeon removed the broken anchor fragments by using a pickup instrument.It cannot be confirmed if all fragments of the broken anchor body were retrieved.However, the surgeon implanted the tenodesis screw directly into the same drilled hole.The case was completed without further issue.The unused portion of the ar-8918cp along with the retrieved broken anchor pieces will be returning for evaluation.

• Brand Name: DELTOID LIGAMENT RECONST IMPLANT SYSTEM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9506095
• Report Number: 1220246-2019-01513
• Device Sequence Number: 2079577
• Product Code: HWC
• UDI-Device Identifier: 00888867131446
• UDI-Public: 00888867131446
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K051726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/20/2019

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: 07/31/2021
• Device Model Number: DELTOID LIGAMENT RECONST IMPLANT SYSTEM
• Device Catalogue Number: AR-8918CP
• Device Lot Number: 10363244
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 12/20/2019
• 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