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 Code	Flaked (1246)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an arthroscopy, at the time of passing through the femur for the tunnel, the low profile drill bit was inserted to tunnel the graft, and it was noticed that the pin passing drill tip was worn, when the drill bit passed through it to make the tunnel and began to release particles of the pin material leaving the material dispersed in the patient's joint.It was reported that the patient current status is stable.The procedure was completed with non-significant delay using a back-up device.No further complications were reported.
Additional Manufacturer Narrative
H6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned 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 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.Please refer to the instructions for use for precautions and warnings related to the use of the device.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.
Event or Problem Description
It was reported that during an arthroscopy, at the time of passing through the femur for the tunnel, the low-profile drill bit was inserted to tunnel the graft, and it was noticed that the pin passing drill tip was worn, when the drill bit passed through it to make the tunnel and began to release particles of the pin material leaving the material dispersed in the patient's joint.The remaining particles were attempted to be recovered using a shaver, since they were very small and only by using a blade and suction it was possible to obtain a large quantity of them.Some remained because due to the material of the pin they adhered to the tissues, but they were very small particles.It was reported that the patient current status is stable.The procedure was completed with non-significant delay using a back-up device in the originally drilled bone hole and no void was left in the patient.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).H10 b1, b2, b5, h1 and h6: event description, type of reportable event and codes updated.
Additional Manufacturer Narrative
H10: h3, h6: a device deficiency was identified, the root cause of the reported event could not be determined since the device was not returned 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 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 one undated image of the device was provided for review and confirms missing coating from the instrument; however, it does not indicate a root cause.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.Based on the limited information provided the clinical root cause of the reported events could not be determined and we are currently unable to rule out a procedural variance as a contributing factor to the reported event, which does not represent a device malfunction.The material of the pin passing drill is intended for surgical applications and is biologically compatible; however, this device is not approved for implantation; therefore, long-term implantation data is not available.Factors that could have contributed to the reported event include an impact event inconsistent with normal use.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.
Additional Manufacturer Narrative
H10 h3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.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 visual inspection of the returned device finds the drill has some small scratches and biological debris on the distal tip, the shaft is abraded and the surface lifted in areas along the distal half.A clinical review states that one undated image of the device was provided for review and confirms missing coating from the instrument; however, it does not indicate a root cause.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.Based on the limited information provided the clinical root cause of the reported events could not be determined and we are currently unable to rule out a procedural variance as a contributing factor to the reported event, which does not represent a device malfunction.The material of the pin passing drill is intended for surgical applications and is biologically compatible; however, this device is not approved for implantation; therefore, long-term implantation data is not available.Factors that could have contributed to the reported event include an impact event inconsistent with normal use.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.

• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18767748
• Report Number: 1219602-2024-00336
• Device Sequence Number: 12674028
• Product Code: HWE
• UDI-Device Identifier: 03596010591265
• UDI-Public: 03596010591265
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/26/2024

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: 7208678
• Device Lot Number: 2130006
• 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: 02/03/2024
• Supplement Date Received by Manufacturer: 04/04/2024; 04/08/2024; 05/14/2024; 06/25/2024
• Initial Report FDA Received Date: 02/23/2024
• Supplement Report FDA Received Date: 04/05/2024; 04/18/2024; 05/16/2024; 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2023
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 90 KG