MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HAT-TRICK PIP FUS 2.7MMPROX 4MM10DEG+MID; SCREW, FIXATION, BONE

Model Number	72204370
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	07/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during use, when inserting the proximal portion of the pip implant, the implant sheared in half and broke off while part of it was still in the patient and it was unable to be removed from the bone.Surgery was resumed, after a non-significant delay, with a change on the surgical technique; toe pinning.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: the shipping information was provided; however, the subject device was not made available to the designated complaint unit and thus a physical product evaluation could not be performed.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 review of the material specification found that a statement (c of c) or evidence of conformance to material and processing specification must be provided.A clinical review states that there were no clinical factors found which would have contributed to the event.If a portion of the implant remains retained in the patient, it is made of a biocomposite material which is intended for implantation to allow for bone ingrowth.If the implant was retained, it is unknown if the broken piece will migrate and there is potential risk for tissue inflammation and/or pain.An analysis of the customer provided images found the anchor had become fractured.Factors that could have contributed to the reported event include an impact inconsistent with normal use or excessive force.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: HAT-TRICK PIP FUS 2.7MMPROX 4MM10DEG+MID
• Common Device Name: SCREW, 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: 15241299
• Report Number: 1219602-2022-01172
• Device Sequence Number: 6456956
• Product Code: HWC
• UDI-Device Identifier: 00885554034943
• UDI-Public: 00885554034943
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K133515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2023

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: 12/01/2023
• Device Model Number: 72204370
• Device Catalogue Number: 72204370
• Device Lot Number: 50908933
• 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: 07/29/2022
• Supplement Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown