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

Catalog Number	013562
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3, 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.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.A review of the device assembly found that before placing the bone tunnel plugs into their bag, the operator must verify that the bone tunnel plugs are clean and free of debris, without discolorations, no burrs or nicks, and no sharp edges.A clinical review states that based on the information provided, and the report that the bone tunnel plug ¿was in very poor condition¿ the clinical root cause of the reported events was likely the result of a user technique vs procedural variance, which does not represent a device malfunction.The device ifu does note that ¿prior to use, inspect the device to ensure it is not damaged.Do not use a damaged device.¿ the bone tunnel plug is an externally communicating device, it is neither manufactured nor intended for implantation.Long-term implantation data is not available.If bone tunnel plug fragments were retained local irritation/discomfort, and/or migration should not be ruled out.Please refer to the instructions for use for precautions and warnings related to the use of the device.Based on this investigation, the need for corrective action is not indicated.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an arthroscopy, the bone tunnel plug, was in very poor condition and broke.The procedure was completed using a back-up device.There was no surgical delay and no further complications were reported.

• Brand Name: BONE TUNNEL PLUG LARGE 10-11MM
• Common Device Name: 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: 19532582
• Report Number: 1219602-2024-01282
• Device Sequence Number: 7501249
• Product Code: NBH
• UDI-Device Identifier: 03596010091147
• UDI-Public: 03596010091147
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 013562
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2024
• Supplement Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 20 YR
• Patient Sex: Male