MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PIN PASSING DRILL TIP 2.4X381MM STRL; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	7208678
Medical Device Problem Codes	Material Separation (1562); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an acl arthroscopy, the guide wire at the drill tip was damaged and worn by the drill.The doctor likely moved its position while it was being used to make the tunnel, causing the damage.The procedure was completed without surgical delay using a smith & nephew back-up device.No further complications were reported.
Additional Manufacturer Narrative
H11: internal complaint reference (b)(4).H3, h6: the reported device was received for evaluation.A visual evaluation showed one device was returned but not in any original packaging.The proximal end of the shaft has come in contact with a sharp instrument which has shaved two sections of metal from the device and deformed it.The sections of metal were not returned.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.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.The root cause was associated with a component failure.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device or wear from prolonged use.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: PIN PASSING DRILL TIP 2.4X381MM STRL
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: 22038597
• Report Number: 1219602-2025-01167
• Device Sequence Number: 12797455
• Product Code: HWE
• UDI-Device Identifier: 03596010591265
• UDI-Public: 3596010591265
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2025

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: 7208678
• Device Lot Number: 2151381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2024
• 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 Age: 14 YR
• Patient Sex: Male