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

Model Number	72203842
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during an unknown procedure, the suturefix ultra was broken in the hole.All the pieces were removed from the patient by suction.The procedure was successfully completed without delay using a back-up device in the same bone hole.No further complications reported.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.A visual inspection revealed the device was not returned with original packaging.Anchor and suture are missing and the suture cover and xl.Sl.Nose tube is missing from device.No other physical damage is visible to the device.A functional evaluation of the returned device is not applicable as device has been actuated.Based on the condition of the product material found during visual inspection no fracture of the implant could be confirmed.Additional material testing is not required.It was determined the device contributed to the reported event.The complaint was confirmed and the root cause associated with unintended use error.Factors that could have contributed to the reported included excessive force.A complaint history review concluded this was a repeat issue.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 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.A review of the material found there are requirements for conformance and a certificate of material analysis is required.No containment or corrective actions are recommended at this time.Our clinical investigation concluded: per case details, the broken fragments were retrieved from the patient.The procedure was completed using a back-up device.No patient injuries or adverse consequences were reported.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.

• Brand Name: SUTUREFIX ULTRA AHR XL 2 UB BLUE/WH
• 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: 12695122
• Report Number: 1219602-2021-02356
• Device Sequence Number: 17150590
• Product Code: MBI
• UDI-Device Identifier: 00885554031553
• UDI-Public: 00885554031553
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K122059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2022

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: 10/21/2021
• Device Model Number: 72203842
• Device Catalogue Number: 72203842
• Device Lot Number: 50627120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2021
• Supplement Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 10/26/2021
• Supplement Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2016
• 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 Sex: Unknown