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

Model Number	OM-1502
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reference number: (b)(4).
Event or Problem Description
It was reported that two magnum 2 knotless implants were used in a rotator cuff repair without issues.However, after the surgery, an x-ray was performed and a piece of metal seemed to be in the joint space.There was no delay and the same device was used to complete the procedure with no complications reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Event or Problem Description
It was reported that, during a shoulder operation, magnum 2 knotless implant was used in a rotator cuff repair without issues.However, after surgery, an x-ray was performed and a piece of metal seemed to be in the joint space, and it was confirmed the implant broke off inside the patient's shoulder.In consequence, the patient had to undergo through a revision surgery to remove the broken piece of the implant that was stuck in his shoulder.Finally, the surgeon had to dig out a big bone hole and place a new anchor of the same reference to complete the case.There was no delay and no additional complications were reported.The patient outcome is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).H3, h6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The complaint history review found further instances of the reported event.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files found that the reported failure was documented appropriately.A review of the customer provided x-ray confirmed a piece of metal to be in the joint space.A review of the drawing found the material specifications are verified for compliance.The provided analysis of the single undated, unlabeled x-ray provided confirmed the presence of a metal piece in the patient¿s joint.However, without the requested clinical information, pre/post revision x-rays, implantation/revision reports or the s&n device, the root cause of the reported metal tip breakage cannot be determined.Although we cannot rule out a procedural variance as the likely cause of the reported event.The ifu warns: ¿do not over tension the suture.- use care to properly align the implant and inserter handle with the bone hole while inserting the implant into the bone hole.¿ although the second anchor is implantable, it was reported the anchor was in a, ¿big bone hole¿ without sutures.Based on the information provided, it is unknown if the second anchor is secure.Therefore, we cannot rule out the possibility of micro-motion or migration of the unsecured anchor.There was a relationship found between the subject device and the reported incident.The complaint was confirmed.Factors unrelated to the manufacture or design of the device that could have contributed to the reported event includes: (1) improper suture loading, (2) excessive tensioning or (3) improper alignment of the inserter handle with the bone hole.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
Event or Problem Description
It was reported that the magnum 2 knotless implant was used in a rotator cuff repair without issues.However, after the surgery, an x-ray was performed and a piece of metal seemed to be in the joint space.Additionally, although the interlocking plug stayed in the anchor, the sutures pulled out after the plug was deployed.The metal piece was retrieved via revision surgery.There was no delay and no other complications reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• 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: 11378373
• Report Number: 3006524618-2021-00239
• Device Sequence Number: 3847344
• Product Code: MBI
• UDI-Device Identifier: 00817470005486
• UDI-Public: 00817470005486
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K042914
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/30/2021

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: 05/30/2022
• Device Model Number: OM-1502
• Device Catalogue Number: OM-1502
• Device Lot Number: 2028635
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 02/22/2021; 02/23/2021; 06/29/2021
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 03/05/2021; 03/18/2021; 06/30/2021
• 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: Required Intervention