MAUDE Adverse Event Report: SMITH & NEPHEW, INC. AWL-DILATOR TWINFIX ULTRA 5.5MM; ACCESSORIES,ARTHROSCOPIC

Catalog Number	72202634
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
Additional Manufacturer Narrative
H11: internal complaint reference (b)(4).H6: this complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate to known risks with the device itself or with its use that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that, during a rotator cuff repair, upon inserting the male component of the awl-dilator twinfix into the patient's bone, the tip broke due to the bone being too hard, it could not be removed.The tip of the product remained embedded in the patient's bone.It is unclear how the procedure was completed; however, there was no surgical delay.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H11 h3, h6: the reported device was received for evaluation.A visual evaluation showed the device was not returned in any original packaging.The laser etching matches the complaint.The flat proximal end of the handle has indentions from being struck multiple times.The distal tip has fractured away and was not returned.The failure is associated with a well-known failure mode that has been thoroughly investigated in prior complaints.No new information, trends, or patient impact were identified that would warrant further review.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specification 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 that based on the information provided we are currently unable to rule out a procedural variance as a contributing factor to the reported event.The device ifu does note that, ¿when a larger hole is required, as in the case of hard bone, reusable drills and awl dilators specific to the suture anchor¿ and ¿use of excessive force during insertion can cause failure of the suture anchor or insertion device.¿ the awl-dilator is made of material is 303 stainless steel.The device is an externally communicating device, it is neither manufactured nor intended for implantation.It is also not approved for long term internal tissue exposure and long-term implantation data is not available.The patient impact is determined to be the retained non-implantable awl-dilator fragment.Migration is unlikely as it was noted that the bit was left within the bone.A definitive root cause for the reported issue could not be determined.Factors that could have contributed to the failure include procedural variance, or deviations from established protocols, increasing risks and leading to unintended consequences (application of unintended inappropriate or excessive force to the device).Based on this investigation, the need for corrective action is not indicated.

• Brand Name: AWL-DILATOR TWINFIX ULTRA 5.5MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• 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: 23631470
• Report Number: 1219602-2025-02969
• Device Sequence Number: 13095613
• Product Code: NBH
• UDI-Device Identifier: 03596010647641
• UDI-Public: 3596010647641
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• 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): 05/04/2026

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: 72202634
• Device Lot Number: 50559307
• 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: 04/28/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR
• Patient Sex: Male