MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. TREK POWER DRIVER; BIOPSY INSTRUMENT

Model Number	TKDRIVER
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: d4 (expiration date: 05/2028).H11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that during a bone biopsy procedure, device allegedly had mechanical jam.There was no reported injury.
Additional Manufacturer Narrative
H10: manufcaturing review: the device history records were requested and reviewed.The lot met all release criteria and no manufacturing related issues were identified.Investigation summary: one trek power driver was received for evaluation.Product packaging and label were returned and product information was verified with tw.The device appeared to have residue on the variable speed trigger.No visual anomalies were noted to the device.During functional testing, the trigger was pulled and it was noted that the motor continues to rotate after releasing the trigger.The device was then disassembled by removing the trigger seal.It was noted that no silicone was observed within the trigger seal.The trigger was pulled once more and it was noted the motor brake engaged properly.Also, an electronic video was provided and reviewed.The video is approximately 00:05 minutes long.The video shows one trek power driver laying on a flat surface.The trek power driver trigger and hex head are visible.The user is seen depressing the trigger and the hex head begins to rotate.The user is seen releasing the trigger yet the hex head continues to rotate.A second attempt is initiated by the user, the user depressing the trigger and the hex head begins to rotate.The user releasing the trigger yet again the hex head continues to rotate.Therefore, based on the video review and returned sample evalaution, the investigation is confirmed for the reported mechanical jam as the trek power driver hex head continued to rotate after release of the trigger.The definitive root cause for the reported mechanical jam (trek power driver hex head continued to rotate after release of the trigger) was due no silicone within the trigger seal.Labeling review: the labeling/packaging review was not required as the reported event is not associated with a labeling, packaging, or use related issue.H10: d4 (expiration date: 05/2028), g3, h6 (method).H11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that during a bone biopsy procedure, device allegedly had mechanical jam.There was no reported injury.

• Brand Name: TREK POWER DRIVER
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): CAREFUSION MANNFORD; 400 foster rd; mannford OK 74044
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 17339977
• Report Number: 2020394-2023-00527
• Device Sequence Number: 20558688
• Product Code: KNW
• UDI-Device Identifier: 00801741201356
• UDI-Public: (01)00801741201356
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K213896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2023

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 Model Number: TKDRIVER
• Device Catalogue Number: TKDRIVER
• Device Lot Number: 0001511235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2023
• Supplement Date Received by Manufacturer: 11/03/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 11/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown