MAUDE Adverse Event Report: ARTHREX, INC. OATS KIT FOR 16MM ALLOGRAFT PLUGS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number OATS KIT FOR 16MM ALLOGRAFT PLUGS

Device Problem Fitting Problem (2183)

Patient Problem No Code Available (3191)

Event Date 08/04/2020

Event Type  Injury  

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 Description

It was reported by the sales rep, who was present, that during a (b)(6) 2020 oca case 16mm fresh plugs from lifenet (lifenet id: 2017189-7006, code: rfp16, exp: 2020-08-14) and an arthrex 16mm oats disposable kit, abs- 1981-16s (lot 10634212) were being used.Surgeon is well accustomed to arthrex oats techniques and has performed many mega oats case and autograft oats case where all the implantation are press fit as well.The technique where the kit and plug are used together is a press fit implantation.When the plug was inserted during this procedure reporter states they could visualize the inferior border of the plug which was described to be no where near press fit, yet even line to line with the border.Reporter states all correct technique protocols for reaming the recipient hole and then using the alignment road.Surgeon double check the measurements of the four quadrants twice to confirm the depth of the desired plug.Reporter states he was unsure if the malfunction was on the kit dies or the actual plug side of the procedure.In order to achieve desired fixation a headless compression screw was used as the plug by itself was wobbly.Patient was reported to be young and healthy and have great bone.Additional information obtained 8/6/2020: the lug was purchased directly through lifenet.The arthrex disposable kit was discarded after the case.The pin was placed into the donor site, then reamed.Surgeons initially recorded measurements.Then slid over the cannulated alignment rod and then took another round of measurements to double confirm the depth of the plug needed.

• Brand Name: OATS KIT FOR 16MM ALLOGRAFT PLUGS
• Type of Device: 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: 10431314
• MDR Text Key: 203832820
• Report Number: 1220246-2020-02063
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867295292
• UDI-Public: 00888867295292
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OATS KIT FOR 16MM ALLOGRAFT PLUGS
• Device Catalogue Number: ABS-1981-16S
• Device Lot Number: 10634212
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/05/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1