MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BONE TUNNEL PLUG SMALL 7MM; ACCESSORIES,ARTHROSCOPIC

Catalog Number 013560

Device Problem Break (1069)

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

Event Date 03/20/2024

Event Type  malfunction  

Event Description

It was reported that during an arthroscopy, the bone tunnel plug broke after being inserted into the patients tibia.It became very brittle and shattered.The broken pieces were removed using a grasper and the shaver with suction.The procedure was successfully completed without surgical delay using a smith and nephew back up device.No further complications were reported.

Manufacturer Narrative

Internal complaint reference: (b)(4).

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 that the tip of the bone tunnel plug device was broken.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, 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 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 unintended inappropriate or excessive force to the device, attempted correction of a damaged device, or 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.

Manufacturer Narrative

Corrected data: b5 and h6:health effect - impact code.

Event Description

It was reported that during an arthroscopy, the bone tunnel plug broke after being inserted into the patients tibia.It became very brittle and shattered.The broken pieces were removed using a grasper and the shaver with suction.The procedure was successfully completed with a delay of less than 30 minutes using a smith and nephew back up device.No further complications were reported.

• Brand Name: BONE TUNNEL PLUG SMALL 7MM
• 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: 19073680
• MDR Text Key: 339942411
• Report Number: 1219602-2024-00733
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010091123
• UDI-Public: 03596010091123
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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: 05/09/2024

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: 013560
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/09/2024
• Supplement Dates Manufacturer Received: 05/06/2024; 05/06/2024
• Supplement Dates FDA Received: 05/08/2024; 05/09/2024
• 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