MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN LINEAR MANUAL INSTR; ACCESSORIES,ARTHROSCOPIC

Catalog Number UNKNOWN

Device Problem Break (1069)

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

Event Date 10/20/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during a knee arthroscopy, the grasper had its jaws broken off within the patient.All the broken pieces were removed with another grasper.The procedure was completed using a smith and nephew back up device.It is unknown if there was a surgical delay.No further complications were reported.

Event Description

It was reported that during a knee arthroscopy, the grasper had its jaws broken off within the patient.All the broken pieces were removed with another grasper.The procedure was completed using a smith and nephew back up device.There was no surgical delay and no further complications were reported.

Manufacturer Narrative

H2: additional information: b5: event description.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).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, complaint history review, risk management 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.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.

• Brand Name: UNKNOWN LINEAR MANUAL INSTR
• 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: 18132916
• MDR Text Key: 328273596
• Report Number: 1219602-2023-02227
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2024
• 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