MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWIST DRILL FLEX CRVD FOR 2.3 SA; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72203160
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that after a procedure, where a twist drill flex was used, a follow up x-ray that was made to the patient during his post-operatory process, showed the physician broke the tip off the twist drill in the patient´s hip, however the physician did not notice this at the time of the procedure, only after the x-ray took place.A ct scan was ordered by the physician to acknowledge if this issue could be problematic, and it was determined that this event could result being a possible issue to the patient if another mri were to be needed at some point.The patient´s current health condition is good, recovering from the procedure without issue.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).H3, h6: a device deficiency was identified; however, the root cause of the reported event could not be determined since the device was not received 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 provided undated, unlabeled x-ray image confirms the presence of a foreign object within the hip and appears in the joint space.However, based on the limited information provided, no clinical factors were found which would have contributed to the reported drill tip breakage.Although, we cannot rule out a procedural versus user error as the likely cause of the reported failure.Since the drill tip is retained but it¿s unknown how secure it is to motion; therefore, we cannot rule out the potential for micro-motion/migration, local skin irritation, and pain.Although, we cannot make conclusions on the impact of the non-implantable foreign body.According to the report, once the surgeon was aware of the x-ray findings, they concluded it could ¿be problematic if the patient should need another mri at some point.¿ per the report, a revision surgery has not been planned to remove the twist drill tip from the patient's hip at this time.Since it was reported the patient is in good health and recovering without any issues, no further clinical/medical assessment is warranted at this time.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: TWIST DRILL FLEX CRVD FOR 2.3 SA
• 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: 16361474
• Report Number: 1219602-2023-00163
• Device Sequence Number: 20718790
• Product Code: MBI
• UDI-Device Identifier: 03596010656018
• UDI-Public: 03596010656018
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K102660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2023

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: 06/21/2023
• Device Model Number: 72203160
• Device Catalogue Number: 72203160
• Device Lot Number: 50743043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2023
• Supplement Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2018
• 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
• Patient Sex: Unknown