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

Model Number	PK1001
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause of this incident could not be determined at this time.Awaiting return of device for further investigation.
Event or Problem Description
It was reported that on (b)(6) 2020, intra-op, the bone was hard and it was managed to insert the product into the pedicle, but the inner cylinder could not be removed and it was unable to proceed to the next step.Therefore the procedure was changed to open.When checking the image to check the level it was found that fragments of the outer cylinder have remained inside the pedicle and inside the vertebral body.An attempt was made to remove the fragments using airtome and a plier but failed and wound closure was performed with the fragments remained based on the surgeon's judgement that the fragments would not come out.There was a delay of more than 60 minutes as a result of this event.There was no patient complications as a result of this event.An update was received on 31 mar 2020: procedure involved: fixation at th10-l3 using voyager 55/60.The bone was hard and when the pak was hammered into the left side of the l2 vertebral body, but the inner cylinder could not be removed.By checking the image, the needle appeared to be bent, so the pak needle itself was pulled out.It was sais at this point, it was noticed that the outer cylinder was broken, but when the image was checked later, it was noticed that a part of the outer cylinder has remained inside the patient's body.It was said that the breakage has occurred to the narrow tip part of the cylinder (near 4cm in scale).In addition when another pak needle was being inserted to the right side of the l2 vertebral body, it was noticed that the pak needle bent overall, and the use of that needle was abandoned.At this point the percutaneous procedure was abandoned and was changed to open procedure, and the operation could not completed.It was said that the left side of the l2 where the pak needle remained has been skipped.

• Brand Name: PAK NEEDLE-BEVEL/BEVEL
• Common Device Name: PEDICLE ACCESS NEEDLE
• Manufacturer (Section D): LACEY MANUFACTURING COMPANY LLC; 1146 barnum avenue; bridgeport, ct
• MDR Report Key: 10157243
• Report Number: 1218017-2020-00003
• Device Sequence Number: 3852678
• Product Code: LXH
• UDI-Device Identifier: 00853508002218
• UDI-Public: (01)00853508002218
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/06/2020

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: 05/07/2022
• Device Model Number: PK1001
• Device Catalogue Number: PK1001
• Device Lot Number: BE3928
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2020
• Initial Report FDA Received Date: 06/16/2020
• 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: Required Intervention
• Patient Age: 64 YR
• Patient Weight: 82