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	01/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during shoulder arthroscopy procedure the anchor was without cut "blunt" and when it was used the doctor pushed the product and it broke.All pieces were successfully removed from the patient.No delay and no back up was available to complete the procedure.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: the device reported, used in treatment, was not returned for evaluation.The relationship between the product and reported incident cannot be established.A review of manufacturing records for the reported lot number \ found no non-conformances or anomalies during manufacturing process related to the reported event.A complaint history review found no related failures; this failure mode will be trended to assess for any necessary corrective actions.A review of the product/print specifications found no discrepancies.Without the reported product a visual inspection and functional evaluation cannot be performed and customer´s complaint cannot be confirmed.Potential factors unrelated to the design or manufacture of the device that may lead to the failure reported include, but are not limited to: (1) excessive probing.(2) misalignment of implant during insertion.(3) shallow bone hole (4) over tensioning.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.
Additional Manufacturer Narrative
The multifix s ultra 6.5mm knotless anchor device, used in treatment, was returned for evaluation.A relationship between the device and reported incident was established.A review of manufacturing records for the reported lot number 2035022 found no non-conformances or anomalies during manufacturing process related to the reported event.A complaint history review found no related failures; this failure mode will be trended to assess for any necessary corrective actions.A review of the product/print specifications found no discrepancies.Visual evaluation shows the device has been returned deployed.The implant is not available.The device is intended for single use and can not be tested.The complaint was verified and 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: (1) excessive force (2) over tensioning the sutures (3) bending or twisting the inserter handle during and after insertion.No containment or corrective actions are recommended at this time.There were no indications 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: 9827516
• Report Number: 3006524618-2020-00109
• Device Sequence Number: 14174560
• Product Code: MBI
• UDI-Device Identifier: 00885556614211
• UDI-Public: 00885556614211
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 06/23/2020

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: 06/11/2022
• Device Model Number: 72290002
• Device Catalogue Number: 72290002
• Device Lot Number: 2035022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2020
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 05/15/2020; 06/18/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 05/18/2020; 06/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1