MAUDE Adverse Event Report: DEPUY SPINE INC SFX,5.5,TI, MED, SIZE F9; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Model Number 189401209

Device Problem Mechanical Jam (2983)

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

Event Date 01/07/2023

Event Type  malfunction  

Event Description

Device report from malaysia reports an event as follows: it was reported that during the final step of a scoliosis surgery on (b)(6)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 sfx,5.5,ti, med, size f9 this is report 6 of 7 for (b)(4).

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.D2b: additional product codes: nkb,mnh,kwp,mni, osh and kwq a manufacturing record evaluation was performed for the finished device product code:189401209 lot no: om11779 it was electronically reviewed and no nonconformances/manufacturing irregularities were identified during the manufacturing process.The product was released on: 26/09/2022 manufacturing site: jabil le locle.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 sfx,5.5,ti, med, size f9 was found jammed in the head of one of the two screws with the tip fragment of the screwdriver.Therefore the rod remained tight because the screw cannot be disassemble.No other issues were found.A dimensional inspection was not performed as it is not applicable to the complaint condition.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 sfx,5.5,ti, med, size f9 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.Drawing/specifications reviewed: the following source controlled drawings reflecting the current and manufactured revisions were reviewed: sfx, ti 5.5 mm, medial series, cross connector assembly, drawing number: eco number: 232925.Rev.F current and manufactured.Dimensional inspection: 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: SFX,5.5,TI, MED, SIZE F9
• Type of Device: ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION
• 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: 17203647
• MDR Text Key: 318203269
• Report Number: 1526439-2023-01172
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 10705034167879
• UDI-Public: (01)10705034167879
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• 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
• Device Operator: Health Professional
• Device Model Number: 189401209
• Device Catalogue Number: 189401209
• Device Lot Number: OM11779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2023
• Initial Date FDA Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ROD, 180MM; ROD, 180MM; SFX TORQUE HANDLE; SFX X20 TORQUE DRIVER SHAFT; SFX X20 TORQUE DRIVER SHAFT; SFX,5.5,TI, MED, SIZE F6; SFX,5.5,TI, MED, SIZE F6
• Patient Age: 16 YR
• Patient Sex: Female
• Patient Weight: 41 KG