MAUDE Adverse Event Report: DEPUY SPINE INC. PRIME STYLET DEPTH ADJUSTOR; SURGICAL DEPTH GAUGE, REUSABLE

Model Number 286750041

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/21/2022

Event Type  malfunction  

Event Description

Device report from depuy synthes reports an event in (b)(6) as follows: this is report 2 of 2 for (b)(4).It was reported by the customer in (b)(6) that during a spinal fusion surgery on (b)(6) 2022, it was observed that the handle from the driver was damaged that the handle was not able to be placed on the screwdriver.It was further reported that the stylet depth adjuster end ring was damaged and completely came off while trying to remove the bent stylet from the screwdriver.Another like devices were used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.This report is for one (1) prime stylet depth adjustor device.This complaint involves two (2) devices.

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The lot number was unknown.Therefore, the expiration date, manufacturing site name and device manufacture date were unknown.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.

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.A review of the receiving inspection (ri) for prime stylet depth adjustor was conducted identifying that lot number mf4292901 was released in one batch.¿ batch1: lot qty of 250 units were released on 27 mar 2018 with no discrepancies.¿ batch1: lot qty of 18 units were released on 09 aug 2019 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the prime stylet depth adjustor has the depth adjuster split sleeve and depth adjuster ring broken off from the complaint device body.No other issues were observed.A dimensional inspection was performed for the prime stylet depth adjustor due to post-manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the prime stylet depth adjustor would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.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.

• Brand Name: PRIME STYLET DEPTH ADJUSTOR
• Type of Device: SURGICAL DEPTH GAUGE, REUSABLE
• Manufacturer (Section D): DEPUY SPINE INC.; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 14137327
• MDR Text Key: 289464990
• Report Number: 1526439-2022-00584
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10705034507644
• UDI-Public: 10705034507644
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K170937
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• 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

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 286750041
• Device Catalogue Number: 286750041
• Device Lot Number: MF4292901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1