MAUDE Adverse Event Report: ARTHREX, INC. IMP SYS INTBRACE KNEE LIG AUGMENT REPR; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	IMP SYS INTBRACE KNEE LIG AUGMENT REPR
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/11/2020
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 that during a (b)(6) 2020 quad tendon repair procedure two of the 4.75 bio-composite swivelocks broke from the ar-5511-cp (internal brace knee ligament augment repair implant system), lot 11087908.The anchors were being used for anchoring two limbs each of 2mm fibertape krakow stitches through the quad tendon and into the patella.The 2.4 mm guide pins were placed in the superior aspect of the patella, advanced 20mm in.They were placed roughly 10mm apart from one another.The pins were checked with c-arm to confirm they were contained within the patella.Once confirmed on ap and lateral shots the pins were over-drilled with the 4.5mm drill from the kit to a depth of 20mm.Once fully drilled the tunnels were tapped with the green tap from the kit all the way to the laser line.The lateral anchor was placed first.Tension on the tape applied and eyelet brought aperture with two taped loaded in the anchor.The anchor was lightly tapped with a mallet until the white anchor body abutted the bone.Then per technique the anchor was advanced.The anchor advanced roughly half of the way in and then broke.There appeared to be 8mm or so of the anchor body in the bone.The fixation was tested and appeared to be strong.At risk of trying to remove the implanted part of the anchor to repeat with a new anchor the anchor was left in place.Before placing the medial anchor an ar-1927ctb tap was used on the medial socket, burying the threads.The anchor was inserted in the same fashion.This anchor broke as well but advanced all the way in except for the last two threads.This fixation was tested and, as the first, seemed to be sufficient.The bone quality is reported to have been very hard although the patient was 73 years old.The eyelet retention fiberwire from the anchors were used to augment the repair as well.The facility is not releasing the devices, keeping them for their internal evaluation.

• Brand Name: IMP SYS INTBRACE KNEE LIG AUGMENT REPR
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10630981
• Report Number: 1220246-2020-02204
• Device Sequence Number: 16907658
• Product Code: MAI
• UDI-Device Identifier: 00888867109698
• UDI-Public: 00888867109698
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/05/2020

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: 05/31/2024
• Device Model Number: IMP SYS INTBRACE KNEE LIG AUGMENT REPR
• Device Catalogue Number: AR-5511-CP
• Device Lot Number: 11087908
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2020
• Initial Report FDA Received Date: 10/05/2020
• 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