MAUDE Adverse Event Report: DEPUY SPINE INC SFX TORQUE HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	289410150
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from malaysia reports an event as follows: it was reported that during the final step of a scoliosis surgery on january 7, 2023, the surgeon input the crosslinks.Upon the final tightening of the crosslinks nuts, the tip of the instrument shaft attached to the torque limiter handle broke off.The fragment of the instrument shaft was stuck inside the crosslink nut recess.As the implant would be very difficult to remove in any future surgery, the surgeon decided to change the crosslink for this patient.Before implanting it in, the surgeon tested the final tightening mechanism outside of the patient's body.The result was that the other instrument shaft also broke off at the tip.Procedure was completed successfully with a twenty minute delay.There was no patient consequence.This report is for a sfx torque handle.This is report 3 of 3 for (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.Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.
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.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 device exhibits signs of normal use.No cosmetic defects were observed on the surface of the device.A dimensional inspection was not performed as it is not applicable to the complaint condition.A functional test was not performed using torque test.An attempt was made to perform a torque test however the device did not detect the limit of the bolt and it could exceed the maximum limit of the equipment 150 lb*in.This showder that the calibration of the handle is wrong.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 sfx torque handle was found to have no cosmetic damages.No definitive root cause could be determined.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.Drawing/specifications reviewed: t-handle torque wrench alluminum, 7 mm hex quick-connect, dwg no.Dgw, rev.E current.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 is report 1 of 7 for (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.

• Brand Name: SFX TORQUE HANDLE
• 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: 16381018
• Report Number: 1526439-2023-00278
• Device Sequence Number: 5898498
• Product Code: LXH
• UDI-Device Identifier: 10705034224367
• UDI-Public: (01)10705034224367
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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: 289410150
• Device Catalogue Number: 289410150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/07/2023
• Supplement Date Received by Manufacturer: 03/31/2023; 06/13/2023
• Initial Report FDA Received Date: 02/15/2023
• Supplement Report FDA Received Date: 04/19/2023; 06/26/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SFX X20 TORQUE DRIVER SHAFT; SFX X20 TORQUE DRIVER SHAFT
• Patient Age: 15 YR
• Patient Sex: Female
• Patient Weight: 41 KG