MAUDE Adverse Event Report: ARTHROCARE CORP. MAGNUM 2 KNOTLESS IMPLANT; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	OM-1502
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/28/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a shoulder procedure the magnum 2 anchor would not load sutures, the anchor could not be used and it was not implanted in the patient.A competitive anchor was used instead.No significant delay or other complications were 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.A relationship between the product and reported incident cannot be established.A review of manufacturing records for the reported lot number 2035907 found no non-conformances or anomalies during manufacturing process related to the reported event.Review of the product instructions for use found adequate warnings and precautions to prevent damage to the device during use.Risk management documents were reviewed finding no additional risks that require to be added to the reference document.Clinical evaluation was completed and concluded that further patient impact is not anticipated as no significant delay and no patient injury was reported.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: improper suture loading.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: MAGNUM 2 KNOTLESS IMPLANT
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10034191
• Report Number: 3006524618-2020-00240
• Device Sequence Number: 3072365
• Product Code: MBI
• UDI-Device Identifier: 00817470005486
• UDI-Public: 00817470005486
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K042914
• 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
• Report Date (Section B): 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/03/2022
• Device Model Number: OM-1502
• Device Catalogue Number: OM-1502
• Device Lot Number: 2035907
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2020
• Supplement Date Received by Manufacturer: 06/05/2020
• Initial Report FDA Received Date: 05/07/2020
• Supplement Report FDA Received Date: 06/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other