MAUDE Adverse Event Report: ARTHROCARE CORP. DOUBLE FIX KNOTLESS PK; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72290143
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/24/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure, when the deployment knob was rotated, the screw could not be inserted in the bone hole.After that, the knob was returned to the original position and it could be deployed.It was noticed by x-ray that the tip of the inserter broke and remains in the anchor inside the patient.There was no delay.No health hazards have been reported for the patient.
Additional Manufacturer Narrative
The reported double fix knotless pk device, intended for use in treatment, was not returned for evaluation.A relationship between the product and reported incident cannot be established as the product was not returned.Without the reported product a visual and functional evaluation cannot be performed and customer¿s complaint cannot be confirmed.From the information provided, ¿during procedure, when the deployment knob was rotated, the screw could not be inserted in the bone hole.After that, the knob was returned to the original position and it could be deployed.It was noticed by x-ray that the tip of the inserter broke and remains in the anchor inside the patient.¿ an exact root cause cannot be determined without evaluation of the device; however, factors unrelated to the manufacture or design of the device that could have contributed to the reported event include: (1) excessive force (2) misalignment of implant or inserter during and after insertion.The instruction for use was reviewed and found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.-if the pound-in tip does not penetrate the bone on the first strike, create a bone hole according to step, use a new anchor in the bone hole.-do not bend or twist the inserter handle during and after insertion as damage to the implant or incomplete insertion may result.-use care to properly align the implant and inserter handle with the bone hole during pound-in.-avoid excessive probing.Do not bend or twist the inserter handle during and after insertion as damage to the implant or incomplete insertion may result there were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: DOUBLE FIX KNOTLESS PK
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8867849
• Report Number: 3006524618-2019-00373
• Device Sequence Number: 13509547
• Product Code: MBI
• UDI-Device Identifier: 00885556722497
• UDI-Public: 00885556722497
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2019

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 Expiration Date: 09/10/2021
• Device Catalogue Number: 72290143
• Device Lot Number: 2021019
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 09/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR