MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX TI 3.5 ULTRABRAID; STAPLE, FIXATION, BONE

Model Number	72200752
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	08/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that one month after an elbow joint procedure with a twinfix ultrabraid, the incision was infected with purulent discharge, which was treated with debridement, bacterial culture, bone cement filling and antibiotics.The symptoms were relieved.The current status of the patient is fine.
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.There was no relationship found between the device and the reported event.A complaint history review found no similar reported events.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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the anchor specifications found no burrs, cracks, or contamination is allowed.A certification of compliance to material and processing specifications is required.As of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.Since the status of the patient is fine, no further clinical/medical assessment is warranted at this time.Should any additional relevant medical information be provided, this case would be re-assessment.The complaint was not confirmed.Factors that could have contributed to the reported event include insufficient or improper cleaning of the surgical site, or a biological response unrelated to the device.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.

• Brand Name: TWINFIX TI 3.5 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: 15812680
• Report Number: 1219602-2022-01740
• Device Sequence Number: 14868031
• Product Code: JDR
• UDI-Device Identifier: 03596010578921
• UDI-Public: 03596010578921
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2022

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: 03/07/2026
• Device Model Number: 72200752
• Device Catalogue Number: 72200752
• Device Lot Number: 2068866
• 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: 10/27/2022
• Supplement Date Received by Manufacturer: 12/07/2022
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 12/09/2022
• Date Device Manufactured: 03/07/2021
• 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: Other; Required Intervention
• Patient Age: 32 YR
• Patient Sex: Male