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

Catalog Number 7207220

Device Problem Flaked (1246)

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

Event Date 01/24/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that forty (40) trocar-tip passing had "metal shavings" coming off when drilling.It is unknown whether the event happened during surgery and if there was patient involvement and if there was a back-up device available or if there was a delay.

Manufacturer Narrative

H3, h6: the reported device was received for evaluation.A visual inspection of the returned devices found that they are in their original, unopened packaging.40 devices were returned.A functional assessment of the devices found no evidence of flaking.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no 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 drawing found that the tip shall not be blunt or have rounded cutting edges and each lot must be accompanied by a material certificate of compliance.The root cause could not be determined since the reported malfunction could not be duplicated during the investigation.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.

Event Description

It was reported that during an acl procedure, forty (40) trocar-tip passing had "metal shavings" coming off when drilling.The procedure was completed with a competitor conmed device with no surgical delay.No further complications were reported.

Manufacturer Narrative

Internal complaint reference case-(b)(4).

Event Description

It was reported that during an acl procedure, forty (40) trocar-tip passing had "metal shavings" coming off when drilling.The piece were removed by irrigation and flushed out.The procedure was completed with a competitor conmed device with no surgical delay.No further complications were reported.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H2: additional information in b5.H11: corrected information in h6 (health effect - impact code).

• 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: 18771498
• MDR Text Key: 336177676
• Report Number: 1219602-2024-00347
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 03596010375315
• UDI-Public: 03596010375315
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7207220
• Device Lot Number: 2137349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2023
• 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