MAUDE Adverse Event Report: LACEY MANUFACTURING COMPANY LLC PACK NEEDLE-BEVEL/TROCAR; PEDICLE ACCESS NEEDLE

Model Number	PK1003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pedicle access needle was returned to the manufacturer and analysis completed.Visual examination was performed on the devices, the two cannulas exhibited evidence of damage consistent with severe manipulation and misuse.One cannula exhibited a torsional failure breakage.There appeared to be evidence of an accessory being attached to the handle which may have contributed to the brakeage.The second cannula exhibited a failure mode whereby the cannula broke from what appear to be excessive side to side bending motion.The device history record for the batch was reviewed and no nonconformances were observed.All records confirmed that the device met the product specification.
Event or Problem Description
It was reported that during intr-op, needle that was used to access the patients pedicle bone broke.The fragment left in the patient.There was no patient injury, complication, surgery delay, or additional surgical intervention reported.

• Brand Name: PACK NEEDLE-BEVEL/TROCAR
• Common Device Name: PEDICLE ACCESS NEEDLE
• Manufacturer (Section D): LACEY MANUFACTURING COMPANY LLC; 1146 barnum avenue; bridgeport, ct
• MDR Report Key: 10399815
• Report Number: 1218017-2020-00006
• Device Sequence Number: 11498909
• Product Code: LXH
• UDI-Device Identifier: 00853508002232
• UDI-Public: (01)00853508002232(17)230224(10)BE4063
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/10/2020

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: 02/24/2023
• Device Model Number: PK1003
• Device Catalogue Number: PK1003
• Device Lot Number: BE4063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 08/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1