MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWIST DRILL FLEX CRVD FOR 2.3 SA; STAPLE, FIXATION, BONE

Catalog Number	72203160
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a surgery, the distal tip of one (1) twist drill flex broke during the first drilling.There was a piece left in the patient bone.The procedure was resumed, without any delay, using an equivalent s+n back-up.No further complications were reported.
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).H2: corrected data on e4.H3, h6: the reported device was received for evaluation.A visual inspection revealed the device was not returned in original packaging.The flex and drill bit have detached from the welded shaft.There does not appear to be any missing material.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 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 that based on the information provided the clinical root cause of the breakage could not be determined.A procedural variance as a contributing factor to the reported event could not be rule out.Excessive force can result in instrument failure.The patient impact is determined to be the retained non implantable twist drill flex fragment.Migration is unlikely as it was noted that the bit was left within the bone.The root cause of the reported event could not be determined since findings cannot lead to a clear cause of the reported event.Factors that could have contributed to the reported event include application of an unintended, inappropriate, or excessive force to the device.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: TWIST DRILL FLEX CRVD FOR 2.3 SA
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 23598624
• Report Number: 1219602-2025-02934
• Device Sequence Number: 10314682
• Product Code: JDR
• UDI-Device Identifier: 03596010656018
• UDI-Public: 3596010656018
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2026

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 Catalogue Number: 72203160
• Device Lot Number: 2132962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: 12/31/2025
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2023
• 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