MAUDE Adverse Event Report: DEPUY SPINE INC X15 TORQUE DRIVER; SCREWDRIVER

Model Number	288306100
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: e3: reporter is a j&j employee.Part # 288306100.Lot#: gb131018.Supplier = gauthier.Batch1: lot unit were released on (b)(6) 2021 with no discrepancies.No non conformance reports were generated during production.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 there were no cosmetic defects within the x15 torque driver.A dimensional inspection for the x15 torque driver was not performed, as it is not applicable to the complaint condition.A functional test was performed, using torque meter mountz ez-torq iii id# adaptor.Drawing dwg- rev.D manufactured was used as source of specification.Torque specification for the device was 2.75 ¿ 3.25.Actual measured values range 3.322-3.388.The device was testing high.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed, for the x15 torque driver.There is no indication that a design or manufacturing issue.The over torqueing condition can be attributed to maintenance of the device.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.Drawing/specifications reviewed: the following drawings reflecting the current and manufactured revisions were reviewed: dwg- rev.D / rev.D.Dimensional inspection: n/a.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
It was reported, on an unknown date.That the following devices was received as blind unit.Product code: 288306100, lot#: gb131018, product code: 288306100, lot#: gb0907, product code: 288306100, lot#: gb131018, product code: 288306100, lot#:  gb131018, product code: 288306100, lot#: gb131018, product code: 288306100, lot#: gb131018, product code: 288306100, lot#: gb131018, product code: 288306100, lot#: gb125164, product code: 288306100, lot#: gb125164, product code: 288306100, lot#: gb114663.This report is for one (1) x15 torque driver.This is report 1 of 7 for (b)(4).

• Brand Name: X15 TORQUE DRIVER
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA ; 3035526892
• MDR Report Key: 17137382
• Report Number: 1526439-2023-01089
• Device Sequence Number: 12205814
• Product Code: HXX
• UDI-Device Identifier: 10705034221441
• UDI-Public: (01)10705034221441
• Combination Product (Y/N): N
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 288306100
• Device Catalogue Number: 288306100
• Device Lot Number: GB131018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 06/15/2023
• 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