MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PLUG BONE TUNNEL 9/10 MED.; ACCESSORIES,ARTHROSCOPIC

Catalog Number 013561

Device Problem Break (1069)

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

Event Date 11/14/2023

Event Type  malfunction  

Event Description

It was reported that during an acl reconstruction, three (3) bone plugs broke and disintegrated while being inserted into the tibial tunnel, the broken pieces were removed by using curettes.The procedure was completed with a smith and nephew back up device.There was a delay greater than 30 minutes and no further complications were reported.

Manufacturer Narrative

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

Event Description

It was reported that during an acl reconstruction, four (4) bone plugs broke and disintegrated while being inserted into the tibial tunnel, the broken pieces were removed by using curettes.The procedure was completed with a smith and nephew back up device.There was a delay greater than 30 minutes and no further complications were reported.

Manufacturer Narrative

H10: internal complaint reference case (b)(4).H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation.However, an image evaluation was performed and found six bone tunnel plugs, five bone tunnel devices are broken and one of the bone tunnels does not appear to be 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 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 unintended inappropriate or excessive force to the device, attempted correction of a damaged device, or an impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.

• Brand Name: PLUG BONE TUNNEL 9/10 MED.
• 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: 18268132
• MDR Text Key: 329740321
• Report Number: 1219602-2023-02371
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010091130
• UDI-Public: 03596010091130
• 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
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 013561
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2024
• 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: Initial
• Patient Sequence Number: 1