MAUDE Adverse Event Report: ARTHROCARE CORP. MULTIFIX S-ULT 6.5MM KNOTLESS ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72290002
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that, during a rotator cuff procedure, while tapping the multifix into the bone it broke.The pieces were removed from the patient and there was a backup device available, which was used in the originally drilled bone hole.No significant delay or 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 device reported, used in treatment, was not returned for evaluation.The relationship between the products and reported incident cannot be established.A device history review/batch record review for lot finding no discrepancies from released and operating procedures nor conditions that could contribute to the event.Lot history review for the last 3 years shows 0 (zero) complaint associated to lot number and relevant to the complaint.Without the reported product a fully visual and functional evaluation cannot be performed and customer¿s complaint cannot be confirmed.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 probing.(2) misalignment of implant.No containment or corrective actions are recommended at this time.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: MULTIFIX S-ULT 6.5MM KNOTLESS ANCHOR
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 9392050
• Report Number: 3006524618-2019-00582
• Device Sequence Number: 10896237
• Product Code: MBI
• UDI-Device Identifier: 00885556614211
• UDI-Public: 00885556614211
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 02/19/2020

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: 04/10/2022
• Device Model Number: 72290002
• Device Catalogue Number: 72290002
• Device Lot Number: 2030094
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2019
• Supplement Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 11/29/2019
• Supplement Report FDA Received Date: 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1