MAUDE Adverse Event Report: ARTHROCARE CORP. PLUG BONE TUNNEL 9/10 MED.; ACCESSORIES,ARTHROSCOPIC

Model Number	013561
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a knee procedure, the surgeon effectively loaded an ultrabutton.However, when pulling the graft it teared.There was an endobutton cl ultra (10mm) available and was used as backup.Nonetheless, the surgery complicated given that the medium bone tunnel plug being used fractured inside of the tibial tunnel.The fragment rose to the joint and made it almost impossible to extract.It is unknown if there was a bone tunnel plug backup.After a 3 hour delay, the joint was presumed to be clean of fragments.No patient injury was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10.H3, h6: the reported bone tunnel plug, used in treatment, will not be returned for evaluation.Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the device broke during use.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force applied during use.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the complaint records was performed, further investigation is not warranted at this time.Without the requested relevant clinical information, operative reports or radiographs the root cause of the implant breakage cannot be determined.Additionally, it is ¿presumed¿ the implantable fractured bone plug fragments were not retained.There were no injuries to this patient beyond the three-hour surgical delay.Since the procedure was completed with a backup device, no further clinical/medical assessment is warranted at this time.Should any additional medical information be provided this complaint will be re-assessed.

• Brand Name: PLUG BONE TUNNEL 9/10 MED.
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 9528534
• Report Number: 3006524618-2019-00626
• Device Sequence Number: 16246139
• Product Code: NBH
• UDI-Device Identifier: 03596010091130
• UDI-Public: 03596010091130
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2020

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: 013561
• Device Catalogue Number: 013561
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/04/2019
• Supplement Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 12/28/2019
• Supplement Report FDA Received Date: 03/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1