MAUDE Adverse Event Report: DEPUY SPINE INC SFX,5.5,TI, MED, SIZE F6; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number	189401206
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2023
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.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 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 f6 was found stripped in the head of one of the two screws.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 f6 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.Batch1: lot units were released on 13 july 2021 with no discrepancies.Batch2: lot units were released on 30 aug 2021 with no discrepancies.Batch3: lot units were released on 27 sept 2021 with no discrepancies.Supplier : depuy : (b)(6) 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.
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 (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 f6.This is report 7 of 7 for (b)(4).

• Brand Name: SFX,5.5,TI, MED, SIZE F6
• Common Device Name: ORTHOSIS, SPINAL PEDICLE 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: 17203813
• Report Number: 1526439-2023-01173
• Device Sequence Number: 20518661
• Product Code: MNI
• UDI-Device Identifier: 10705034167848
• UDI-Public: (01)10705034167848
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K142460
• 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

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: 189401206
• Device Catalogue Number: 189401206
• Device Lot Number: OM11486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2023
• Initial Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROD, 180MM; ROD, 180MM; SFX TORQUE HANDLE; SFX X20 TORQUE DRIVER SHAFT; SFX X20 TORQUE DRIVER SHAFT; SFX,5.5,TI, MED, SIZE F9
• Patient Age: 16 YR
• Patient Sex: Female
• Patient Weight: 41 KG