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

Model Number	PK1002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	11/21/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: PEDICLE ACCESS NEEDLE
• Manufacturer (Section D): LACEY MANUFACTURING COMPANY LLC; 1146 barnum avenue; bridgeport CT 06610
• MDR Report Key: 9618390
• Report Number: 1218017-2019-00005
• Device Sequence Number: 19435992
• Product Code: PDQ
• UDI-Device Identifier: 00853508002225
• UDI-Public: (01)00853508002225(17)220801(10)BE3967
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 01/22/2020
• 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: Hospitalization
• Patient Age: 78 YR
• Patient Weight: 85