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

Model Number	72290143
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/03/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during arcr procedure, the anchor broke off from the base.The screw parts dropped off inside the joint, but it was removed with grasper.No patient injury was reported.A backup device was available to complete the procedure with no significant delay and no patient injuries.
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 the device was returned with single parts of the implant attached in a separate plastic bag.The separately returned implant was not damaged.No sutures returned with the instrument.The parts returned show no manufacturing abnormalities.The returned double fix knotless pk is a single used device and cannot be functional tested.The complaint was not verified and the root cause could not be determined with certainty.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.Additional information.
Event or Problem Description
It was reported that during arcr procedure, the anchor broke off from the base.The screw parts dropped off inside the joint, but it was removed with grasper.No patient injury was reported.No additional bone hole was made to complete the procedure and a backup device was available to complete the procedure with no significant delay and no patient injuries.
Additional Manufacturer Narrative
Report was inadvertently submitted under manufacturer number ¿1219602¿ but the correct manufacturer number is ¿3006524618.¿.
Additional Manufacturer Narrative
H10/h11: the initial incident report was submitted with incorrect manufacturing site information and registration number 1219602 (s+n mansfield).The correct manufacturing site information and registration number is 3006524618(s+n austin).Corrected data: d3 and g1 manufacturing site name, address and contact information.

• 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: 8134324
• Report Number: 1219602-2018-01667
• Device Sequence Number: 10816848
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/08/2020

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 Expiration Date: 09/10/2021
• Device Model Number: 72290143
• Device Catalogue Number: 72290143
• Device Lot Number: 2021019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 01/22/2019; 01/22/2019; 01/22/2019
• Initial Report FDA Received Date: 12/05/2018
• Supplement Report FDA Received Date: 01/23/2019; 11/20/2019; 02/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1