MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SUTUREFIX ULTRA AHR S 2 UB STR BLUE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72203852
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	05/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an arthroscopic procedure, after all the correct use of the technique for implantation of the suturefix ultra anchor, there was no fixation in the bone and it loosened.The anchor came out along with the anchor wire and it was removed.The procedure was successfully completed with no surgical delay using a back-up device in an additional drill hole.The first hole was left void and no further complications were reported.
Additional Manufacturer Narrative
H10: h3, h6: the reported device 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.A complaint history review found similar reported events.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 risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.Per case details the loosened anchor was retrieved from the patient and the procedure was completed with a back-up device.An additional bone hole was used, the previous hole was left void.The patient impact is expected to be minimal.Per e-mail, "the surgeon was satisfied with the surgical result, as the other 2 anchors fixed perfectly." since no further harm is anticipated no further clinical investigation is warranted.There was no way to determine if the device contributed to the reported event.The complaint was not confirmed.Factors that may have contributed to the reported event include unintended excessive force on insertion.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.

• Brand Name: SUTUREFIX ULTRA AHR S 2 UB STR BLUE
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14940698
• Report Number: 1219602-2022-00964
• Device Sequence Number: 17686698
• Product Code: MBI
• UDI-Device Identifier: 00885554030037
• UDI-Public: 00885554030037
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K122059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2022

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 Expiration Date: 01/05/2026
• Device Model Number: 72203852
• Device Catalogue Number: 72203852
• Device Lot Number: 2065841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2022
• Supplement Date Received by Manufacturer: 07/15/2022
• Initial Report FDA Received Date: 07/06/2022
• Supplement Report FDA Received Date: 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 34 YR
• Patient Sex: Female