MAUDE Adverse Event Report: DEPUY SPINE INC EXPEDIUM SPINE SYSTEM TORQUE HANDLE OUTER NUT 4.5; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	286277004
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2023
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.Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.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
It was reported that on (b)(6) 2023, during routine incoming inspection of a loaner set, it was observed that exp4.5 torque handle-outernut was found to be out of drawing specification.The drawing specification is 6.460 nm ¿ 7.540 nm.The torque tested low ¿ 6.017 nm.There was no known patient or hospital involvement.The product has been quarantined and is available and is being returned to the repair site.A replacement device has been ordered.No replacement product is required, and no shipping label is required for the product return.This report is for one (1) expedium spine system torque handle outer nut 4.5 this is report 1 of 1 for complaint (b)(4).
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.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.
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.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 was no damage or defects with the exp4.5 torque handle-outernut.A dimensional inspection for the exp4.5 torque handle-outernut was not performed since it was not applicable to the complaint condition.A functional test was performed using torque meter torquelab ltt-2100, id#cd88573, adaptor vf1031000.Drawing no.Dwg-887040722, rev.B (manufactured) was used as source of specification.Torque handle is required to deliver 6.3-7.7 nm at intermediate setting.Actual measured values range from 6.553 - 6.750 nm.The complaint condition was not replicated because the device passed the torque test.Refer to attachment "(b)(4) test" for results.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the observed condition of the exp4.5 torque handle-outernut would not 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.Drawing/specifications reviewed the following drawings reflecting the current and manufactured revisions were reviewed: torque limiter offset silicone t-handle 10.2mm octagon connect, drawing no.Dwg-887040722, rev.B current and manufactured.A review of the receiving inspection (ri) for exp4.5 torque handle-outernut, was conducted identifying.That lot number gb74762 was released in two batches.Batch1: lot units were released on 29 july 2016 with no discrepancies.Batch2: lot units were released on 22 june 2016 with no discrepancies.Supplier : (b)(4).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.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: EXPEDIUM SPINE SYSTEM TORQUE HANDLE OUTER NUT 4.5
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 16997849
• Report Number: 1526439-2023-00908
• Device Sequence Number: 7067656
• Product Code: LXH
• UDI-Device Identifier: 10705034303116
• UDI-Public: (01)10705034303116
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup,Followup

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: 286277004
• Device Catalogue Number: 286277004
• Device Lot Number: GB74762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2023
• Supplement Date Received by Manufacturer: 06/22/2023; 09/01/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 07/13/2023; 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2016
• 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