MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOUR INTRA DRILL 9.5MM; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 74012111

Device Problem Material Deformation (2976)

Patient Problem Perforation (2001)

Event Date 09/11/2023

Event Type  Injury  

Event Description

It was reported that, during a right tka, while the surgeon attempted to drill bone, the drill slipped and entered the popliteal space pulling out a portion of vein.The surgeon felt the drill bit was dull.It is unknown how procedure was completed and if it was prolonged as consequence.Patient outcome is also unknown.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that, during a right tka, while the surgeon attempted to drill bone, the surgeon plunged the journey intramedulary drill 9.5mm between tibia an femur; when removing the drill from the patient, surgeon realized that the drill entered the popliteal space pulling out a portion of vein.The wound was irrigated and closed.Sterile dressings were applied.The tourniquet was left on to prevent substantial bleeding and patient was transferred out for emergent surgery.An exploration of right popliteal artery, left saphenous vein harvest, and right sfa to below-knee popliteal artery bypass with reverse saphenous vein, and 4 compartment fasciotomy was performed.No blood transfusion was required as consequence of the incident.The surgeon commented the drill bit was dull.Patient was transported out of hospital and currently is at home since (b)(6) 2023 with homecare with plans for a wound vac.The patient was referred to neurology for pain control issues.Surgery was cancelled and has not been rescheduled at this time.

Manufacturer Narrative

H2: additional information ¿b5, h6¿.

Manufacturer Narrative

The correct aware date for the initial report is 11-sep-2023, we receive confirmation of this on 13-oct-2023.

Event Description

It was reported that, during a right tka, while the surgeon attempted to drill bone, the surgeon plunged the journey intramedulary drill 9.5mm between tibia an femur; when removing the drill from the patient, surgeon realized that the drill entered the popliteal space pulling out a portion of vein.The surgeon began to close the joint and asked for the patient to get transferred.The surgeon commented the drill bit was dull.Patient was transported out of hospital and currently is at home.

Manufacturer Narrative

D4 has been updated.The associated device was returned and evaluated.A visual inspection of the returned device reveals both ends of the device is stripped and rounded off.The device shows signs of significant wear and use.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.The clinical/medical evaluation concluded that based on the documentation provided, no clinical factors have been identified which would have contributed to the reported event and user technique cannot be ruled out.Without the operative report, we are unable to confirm the use of the distal femoral cutting block as indicated.It be concluded that the reported adverse event was associated with mal performance of the s&n intramedullary drill.It was reported the patient¿s follow-up surgery has not been scheduled and she is pending both a wound vac placement and a neurology pain consultation.The impact of the reported event is the extensive vascular surgery to repair the popliteal vein damage and associated recovery and possible pain as noted that needing neurology pain consult.It is not known how the knee was stabilized as the tka was paused during the vein injury.As it was noted the tka was not rescheduled so functional impact is also likely.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A review of instructions for use for care, maintenance, cleaning and sterilization of smith & nephew orthopedics devices revealed that visually inspecting for damage or wear, including components in their disassembled state prior to re-assembly as well as ensuring components are re-assembled securely is indicated.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: JOUR INTRA DRILL 9.5MM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 17909721
• MDR Text Key: 325338386
• Report Number: 1020279-2023-01927
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/08/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74012111
• Device Lot Number: 13JM06209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/09/2023
• Initial Date FDA Received: 10/10/2023
• Supplement Dates Manufacturer Received: 10/13/2023; 11/02/2023; 12/07/2023
• Supplement Dates FDA Received: 10/17/2023; 11/07/2023; 12/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female