MAUDE Adverse Event Report: DEPUY SPINE INC BALL TIP FEELER CURVED; PROBE

Model Number	275010140
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2021 during pedicle probe step of procedure to ensure there isn¿t a pedicle breach, the end tip of the pedicle probe broke off in the patients l5 vertebral body.Procedure completed successfully without any surgical delay.This report is for one (1) ball tip feeler straight.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j sales representative.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
This report is for one (1) ball tip feeler curved.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.D4: lot number.H3, h6: a product investigation was conducted.The product was returned to depuy synthes cq for evaluation.The depuy synthes cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample as well as the photo revealed that the ball tip feeler curved was broken in two places.The feeler shaft was broken off at the proximal connection point to the handle, and at the distal end near the ball.The distal end was not returned.The uploaded photo shows a broken off portion of the device embedded in the patient.No other issues were identified.The dimensional inspection was performed on the returned device and it was measured to be within specification the observed condition ball tip feeler curved in the device was consistent with a random component failure that may have been caused by exposure to unintended force.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the ball tip feeler curved was observed to be broken, and a broken off portion was shown embedded in the patient.While no definitive root cause could be determined, it is probable that the ball tip feeler curved broke due to unexpected forces.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Manufacturing record evaluation (mre) was not performed since no manufacturing related potential cause is suspected.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.B5; d1.D4: corrected catalog number and udi number.

• Brand Name: BALL TIP FEELER CURVED
• Common Device Name: PROBE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 13226818
• Report Number: 1526439-2022-00071
• Device Sequence Number: 4111710
• Product Code: HXB
• UDI-Device Identifier: 10705034194066
• UDI-Public: (01)10705034194066
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 275010140
• Device Catalogue Number: 275010160
• Device Lot Number: 0705V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/15/2021
• Supplement Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 01/11/2022
• Supplement Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown