MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BONE TUNNEL PLUG LARGE 10-11MM; ACCESSORIES,ARTHROSCOPIC

Catalog Number 013562

Device Problem Fracture (1260)

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

Event Date 02/07/2024

Event Type  malfunction  

Event Description

It was reported that during an acl reconstruction procedure, the surgeon used the bone tunnel plug (spigots) 10mm into the tibial hole after preparation to stop water from exiting the joint and once he removed it, the spigots crumpled into pieces and broke inside the patient joint.The surgeon therefore spent approximately 20 minutes extra of intraoperative time to remove the spigots pieces inside the patient using an arthroscopic grasper and suction.The procedure was completed with a surgical delay of less than 30 minutes using the same device.No further complications were reported.

Manufacturer Narrative

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

Manufacturer Narrative

H2: additional information on: e1.

Manufacturer Narrative

H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation.However an image evaluation was performed and found one bone tunnel plug outside of its box, broken and with bio debris.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.The root cause of the reported event could not be determined since findings cannot lead to a clear cause of the reported event.Factors that could have contributed to the reported event include an application of excessive / inappropriate force on the device.No containment or corrective actions are recommended at this time.

• Brand Name: BONE TUNNEL PLUG LARGE 10-11MM
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• 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: 18905585
• MDR Text Key: 337691183
• Report Number: 1219602-2024-00493
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010091147
• UDI-Public: 03596010091147
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/23/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 013562
• Device Lot Number: 0740761-1A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 03/14/2024
• Supplement Dates Manufacturer Received: 03/18/2024; 04/19/2024
• Supplement Dates FDA Received: 03/19/2024; 04/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2023
• 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 Sex: Male