MAUDE Adverse Event Report: DEPUY SPINE INC ROD, 480 MM; PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS

Model Number	179762480
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
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 and kwq product code: 179762480 lot number: bdi4gsv update by (b)(6) on (b)(6) 2023 - the lot # bdi4gsv does not exist in sap p02.Dhr review cannot be completed 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 rod, 480 mm was found broken in middle and was appreciated deformed/bent.The broken fragment was not returned.The reported condition can be confirmed.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 rod, 480 mm 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: expedium 5.5 mm rod ti 300/480 mm hex end, drawing number 1797-62-300 / 480, eco number 226678, rev.F current and manufactured.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
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 a rod, 480 mm this is report 5 of 7 for (b)(4).

• Brand Name: ROD, 480 MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS
• 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: 17203600
• Report Number: 1526439-2023-01171
• Device Sequence Number: 20254933
• Product Code: OSH
• UDI-Device Identifier: 10705034077437
• UDI-Public: (01)10705034077437
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K111136
• 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: 179762480
• Device Catalogue Number: 179762480
• Device Lot Number: BDI4GSV
• 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
• 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: 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; SFX,5.5,TI, MED, SIZE F9
• Patient Age: 16 YR
• Patient Sex: Female
• Patient Weight: 41 KG