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

Model Number	013561
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).
Event or Problem Description
It was reported that, during an acl reconstruction procedure, upon inserting the bone plug into the tibial tunnel, the shaft of the plug broke off in the tunnel.A smaller bone plug was used to push the broken piece further up the tunnel and into the joint space to retrieve it via the portal using a grasper but when attempting to grasp, the broken piece was so brittle that it disintegrated into numerous tiny pieces.Some of the pieces were removed using a grasper and the shaver but it is unknown if all pieces were retrieved.The procedure was completed with non significant surgical delay by filling the tibial bone tunnel with a hamstring tendon and interference screw.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H10, h3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.It was determined the device contributed to the reported event.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 specification upon release for distribution.A complaint history review found similar reported events.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the customer provided image found a fractured plug that appears to be extremely worn from use with a chalky exterior and markings completely devoid of color.Per case details, the broken pieces were not retrieved from the patient.The patient¿s bone quality was normal, and no void was left in the patient.A smith and nephew backup device was not used.The patient was reportedly ¿stable at discharge".The bone plug is manufactured and intended as externally communicating devices and are not approved for long term internal tissue exposure and long-term implantation data is not available.The patient impact beyond possible micro-motion and/or migration, and local irritation/discomfort cannot be determined.No further medical assessment can be rendered at this time.The complaint was confirmed, and the root cause was associated with component failure.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, an impact event inconsistent with normal use, or wear of the device from repeat use.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: PLUG BONE TUNNEL 9/10 MED.
• 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: 14080218
• Report Number: 1219602-2022-00517
• Device Sequence Number: 5277489
• Product Code: NBH
• UDI-Device Identifier: 03596010091130
• UDI-Public: 03596010091130
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 013561
• Device Catalogue Number: 013561
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2022
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 05/25/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown