MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BONE ANCHORS 3 W ARTHRO DEL SYS ADVNCD; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	4403
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).H3, 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 inherent device and/or procedural risks 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 surgery, when creating the bone holes for the fixation of the regeneten implant, the prongs of one (1) bone punch buckled and bent on the second tap with the mallet.The surgeon tried to bend it back into place but because of the potential risk of snapping inside the patient's bone, they opened a new device.The surgeon had to create and use separate holes to place the next bone anchor.The regeneten implant was successfully placed.The procedure was resumed, without any delay, using an equivalent s+n back-up.No further complications were reported.

• Brand Name: BONE ANCHORS 3 W ARTHRO DEL SYS ADVNCD
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: holly topping ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 23464154
• Report Number: 3003604053-2025-00057
• Device Sequence Number: 13032861
• Product Code: LXH
• UDI-Device Identifier: 00854501006159
• UDI-Public: 854501006159
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K131635
• 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
• Report Date (Section B): 11/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 4403
• Device Lot Number: 2181947
• 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: 10/16/2025
• Initial Report FDA Received Date: 11/04/2025
• Date Device Manufactured: 04/30/2025
• 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
• Patient Sex: Unknown