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

Model Number	PK1002
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The root cause of the incident could not be determined at this time.Waiting on return of device for further investigation.The device history record for the device lot was reviewed and there were no indications of a manufacturing problem or defect.
Event or Problem Description
Procedure performed : percutaneous insertion of pedicle screws.Levels implanted l1-s2.It was reported on (b)(6) 2019, intra-op, the taper tip of the pak needle was broken and remains in the vertebral body of the patient.Some drilling down the pedicle had to be done to try and retrieve the portion of the pak needle that had broken off.The product came in contact with the patient.There were no patient symptoms or complications as a result of this event.

• Brand Name: BEST PAK NEEDLE TROCAR/TROCAR
• Common Device Name: PEDICLE ACCESS NEEDLE
• Manufacturer (Section D): LACEY MANUFACTURING COMPANY LLC; 1146 barnum avenue; bridgeport CT 06610
• MDR Report Key: 9623483
• Report Number: 1218017-2019-00006
• Device Sequence Number: 18978982
• Product Code: LXH
• UDI-Device Identifier: 00853508002225
• UDI-Public: (01)00853508002225(17)220613(10)BE3941
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/09/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/13/2022
• Device Model Number: PK1002
• Device Catalogue Number: PK1002
• Device Lot Number: BE3941
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/30/2019
• Initial Report FDA Received Date: 01/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other