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	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).
Event or Problem Description
It was reported that both suturefix ultra ahr s 2 ub str blue and suturefix ultra ahr s 2 ub str cb blu were use inside the patient during arthroscopy procedure and when the surgeon checked the image immediately after the surgery, a metal piece at the distal tip was left in the glenoid.Piece left in patient.The procedure was finished with the same device.No surgical delay.Patient injuries were not reported.
Event or Problem Description
It was reported that a suturefix ultra ahr s 2 ub str blue was used inside the patient during arthroscopy procedure and when the surgeon checked immediately after the surgery, it was found that a metal piece was left in the glenoid.The piece was not removed from the patient.The procedure was finished with the same device.No surgical delay.No further complications were reported.
Additional Manufacturer Narrative
H2: additional information ¿b5: event description, h6: health effect - clinical code and impact code¿.H3, h6: ¿the reported device was received for evaluation.An analysis of the customer provided images in two pictures showed two devices side by side one straight and one broken/bent and a third image shows an x-ray with a material in a bone.A visual inspection revealed only one device was returned in the carton, but two different lot numbers were on the packaging appearing to signify two devices returned.The returned device is outside of original packaging.The device was returned without anchor, suture, nose tube, and suture cover.The distal tip of the device is broken and appears to have been bent until broken.The device had been fully actuated.A functional evaluation of the returned device is not applicable.A complaint history review concluded this was a repeat event.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.It was determined the device did not contribute to the reported event.The complaint was confirmed and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include excessive force applied to the inserter.Per the complaint details, the surgeon used the suturefix ultra ahr s 2 ub str blue and suturefix ultra ahr s 2 ub str cb blu inside the patient during arthroscopy procedure.According to the report, the attached image was reviewed by the surgeon immediately after the surgery, that revealed a metal piece at the distal tip was left in the glenoid.It was reported the procedure was completed with the same device without a surgical delay or patient injuries.The attached image confirmed the metal piece at the distal tip was retained in the glenoid.However, the root cause of the tip breakage cannot be determined.Although we cannot rule out a procedural variance as the likely cause of the reported issue.The retained metal tip was manufactured and intended as an external communicating device and it has not been approved for long term internal tissue exposure and long-term implantation data is not available.Since it was reported the retained metal tip was in the glenoid, micro-motion and/or migration is unlikely.Based on the information provided, the procedure was completed with the same device without a surgical delay or patient harm.Therefore, no further clinical/medical assessment is warranted at this time.Should any additional relevant patient information be provided, this complaint would be re-assessed.No containment or corrective actions are recommended at this time.¿.

• 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: 12001061
• Report Number: 1219602-2021-01359
• Device Sequence Number: 11615748
• Product Code: MBI
• UDI-Device Identifier: 00885554030037
• UDI-Public: 00885554030037
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2022

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: 03/13/2024
• Device Model Number: 72203852
• Device Catalogue Number: 72203852
• Device Lot Number: 50793354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 02/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2019
• 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