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

Device Problem Flaked (1246)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2024

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event 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.

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 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.

Manufacturer Narrative

Internal complaint reference case (b)(4).H10 b1, b2, b5, h1 and h6: event description, type of reportable event and codes updated.

• Brand Name: PIN PASSING DRILL TIP 2.4X381MM STRL
• Type of Device: 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
• MDR Text Key: 336114778
• Report Number: 1219602-2024-00336
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7208678
• Device Lot Number: 2130006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2024
• Date Device Manufactured: 09/22/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 90 KG