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	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign post code - (b)(6).
Event or Problem Description
It was reported that, during an unspecified surgical procedure, the double fix knotless implant broke.All fragments were retrieved from the patient but it is unknown what medical technique was used.A back-up device was available to complete the procedure without significant delay.The patient was not injured.
Additional Manufacturer Narrative
The returned instrument, intended for use in treatment, was returned as an mdr for evaluation.There was a relationship found between the returned device and the reported incident.Visual inspection of the instrument shows no manufacturing abnormalities.The implant was detached and not received.No suture was returned with the instrument.The returned device is a single used device and cannot be functional tested.The end cap including the rod at distal end can be continuously rotated in both directions.The deployment knob can rotate easily in both directions.The complaint was verified but the root cause could not be determined with certainty.Factors unrelated to the design and manufacture of the device which could have contributed to the complaint event are outlined in the precautionary states in the instruction for use such as (1) if the pound-in tip does not penetrate the bone on the first strike, create a bone hole according to step 3.Use a new anchor in the bone hole and (2) 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: 8665041
• Report Number: 3006524618-2019-00275
• Device Sequence Number: 243382
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2019

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: 11/09/2021
• Device Catalogue Number: 72290143
• Device Lot Number: 2020470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Initial Date Received by Manufacturer: 05/21/2019
• Supplement Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 06/03/2019
• Supplement Report FDA Received Date: 07/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1