MAUDE Adverse Event Report: LACEY MANUFACTURING COMPANY LLC PAK NEEDLE TROCAR/TROCAR; PEDICLE ACCESS NEEDLE

Model Number PK1002

Device Problem Break (1069)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 11/21/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to the manufacturer.The root cause of the incident could not be determined.The device history record for the device lot was reviewed and there was no indication through the review of the dhr of a manufacturing problem or defect.

Event Description

It was reported intra-op, the tip of needle was broken and remained in pedicle both sides.Any complication to the patient was unknown.Update received on 26 nov 2019 the product came in contact with the patient and broken piece had left inside vertebral body.There was complication to the patient as a result of this event.Surgeon will discuss with patient for any revision surgery to explant the broken tips.

• Brand Name: PAK NEEDLE TROCAR/TROCAR
• Type of Device: PEDICLE ACCESS NEEDLE
• Manufacturer (Section D): LACEY MANUFACTURING COMPANY LLC; 1146 barnum avenue; bridgeport CT 06610
• Manufacturer (Section G): LACEY MANUFACTURING COMPANY LLC; 1146 barnum avenue; bridgeport CT 06610
• Manufacturer Contact: james rogers ; 1146 barnum avenue; bridgeport, CT 06610 ; 2033367453
• MDR Report Key: 9618390
• MDR Text Key: 200671066
• Report Number: 1218017-2019-00005
• Device Sequence Number: 1
• Product Code: PDQ
• UDI-Device Identifier: 00853508002225
• UDI-Public: (01)00853508002225(17)220801(10)BE3967
• 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: distributor,foreign
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/20/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2022
• Device Model Number: PK1002
• Device Catalogue Number: PK1002
• Device Lot Number: BE3967
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/11/2019
• Initial Date FDA Received: 01/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2019
• 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): Hospitalization
• Patient Age: 78 YR
• Patient Weight: 85