MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PIN PASSING 2.4MM TROCAR 17; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 7207220

Device Problem Flaked (1246)

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

Event Date 09/16/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, during an arthroscopy, the passing pin, 2.4mm x 17 trocar had extreme metal abrasion of the wire, the chips were removed with difficulty by irrigation and tweezers.Non-significant surgical delay was reported, and the procedure was finished with a smith and nephew back up device.No further complications were reported.

Manufacturer Narrative

H3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.A visual inspection of the returned device found that it is not in its original packaging.The guides have abrasions down the length and biological debris in the channel and on the exterior of the devices.A review of the customer provided image finds metal shavings among biological debris conforming to the damage to the complaint device.The complaint was confirmed, and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include excessive force on the device, attempted correction of a damaged device, off-axis insertion, improper preparation of the insertion site, or an inadvertent impact event inconsistent with normal 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.This case reports the passing pin, 2.4mm x 17 trocar had extreme metal abrasion of the wire.Reportedly, the chips were removed using irrigation and tweezers.As of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.The patient impact beyond the reported cannot be determined.Per case communication, the procedure was completed with a nonsignificant surgical delay using a backup device without additional complications.No patient injury has been reported.Therefore, no further clinical/medical assessment is warranted.A complaint history review found no similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.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.No containment or corrective actions are recommended at this time.

• Brand Name: PIN PASSING 2.4MM TROCAR 17
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 15573311
• MDR Text Key: 301486334
• Report Number: 1219602-2022-01499
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 03596010375315
• UDI-Public: 03596010375315
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7207220
• Device Catalogue Number: 7207220
• Device Lot Number: 2089102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention