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	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after having a biceps tenodesis and rotator cuff repair involving a "multifix s-ultra (6.5mm, knotless anchor)"; the patient was experiencing weakness in his shoulder.So, when he was checked by the medical team, they saw the proximal half of the anchor was loose within the joint space.As a result, the patient went under a revision surgery, which resulted successful and the shoulder was healed with no additional anchors put in place.However, the broken distal end remained implanted in the patient joint.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: h2, h6.The reported device, used in treatment, was not returned for evaluation.A relationship, if any, between the subject device and the reported event could not be determined.No product identification information was provided and thus a manufacturing and product print/specifications records review could not be conducted.A review of risk management files found that the reported failure was documented appropriately.A complaint history review concluded this was an isolate issue.A review of the instructions for use found warning and instruction statements.Without the reported product a visual and functional evaluation cannot be performed and customer¿s complaint cannot be confirmed.Clinical evaluation was completed and concluded that based on the information provided the root cause of the implant breakage cannot be determined.The multifix s-ultra knotless anchor is an implantable device; therefore, compatibility is not an issue.Since the broken distal end of the anchor is implanted in the patient¿s joint migration of the retained broken distal end is unlikely.The impact to the patient was the revision and the retained broken anchor.It was reported the revision was a success, the shoulder was healed, and no additional anchors were required.Should any additional medical information be provided, this complaint will be re-assessed.Factors that could have contributed to the reported event include: (1) potential complications accompanying such implant surgery.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.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• 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: 10819828
• Report Number: 3006524618-2020-00977
• Device Sequence Number: 4011578
• Product Code: MBI
• UDI-Device Identifier: 00885556614211
• UDI-Public: 00885556614211
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K153669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 72290002
• Device Catalogue Number: 72290002
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 12/16/2020
• 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: Required Intervention
• Patient Age: 47 YR