MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX TI 2.8 ULTRABRAID; STAPLE, FIXATION, BONE

Model Number	72200750
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	10/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2021, a right shoulder joint arthroscopy and bankart repair were performed to treat the patient's recurrent right shoulder dislocations.A total of three titanium (3) twinfix ultrabraid suture anchors were used.The patient was discharged on (b)(6) 2021, but one month after surgery, itchy hives started to appear throughout the patient's body, and spread to the limbs, with itching and swelling of the lips.The patient self-kept to a hypoallergenic diet without any effect.The patient took ag (zyrtec, cetirizine) once every 2 days with moderate effect, and linear urticaria (dermographism) began to appear.The patient was diagnosed with chronic spontaneous urticaria (titanium fasteners) and recurrent angioedema.It is unknown what remedial actions were taken and the current health status of the patient is unknown.
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).
Additional Manufacturer Narrative
H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.The instructions for use were 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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states the source of the itchy hives reported to appear throughout his body, spreading to the limbs, the 5¿6-point pruritus and the swelling of the lips cannot be confirmed, but allergy cannot be ruled out.It is unknown if an underlying medical condition, not seeking early medical intervention could have contributed to the unresolved symptoms.However, it was reported the patient has been advised to follow up with an allergist.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.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.Corrected data: h6: health effect - impact code.

• Brand Name: TWINFIX TI 2.8 ULTRABRAID
• Common Device Name: STAPLE, FIXATION, BONE
• 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: 16864593
• Report Number: 1219602-2023-00645
• Device Sequence Number: 5385641
• Product Code: JDR
• UDI-Device Identifier: 03596010584472
• UDI-Public: 03596010584472
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K972326
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2023

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: 01/19/2025
• Device Model Number: 72200750
• Device Catalogue Number: 72200750
• Device Lot Number: 2048129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 05/03/2023
• Supplement Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FLUXUM, RIVAROXABAN AND CEFAZOLIN.
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 32 YR
• Patient Sex: Male