MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CONN O/O SD TOP NTCH 5.5X5.5 T; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	179771555
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2022
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.Additional narrative: additional codes: kwp, kwq, osh, nkb, mni investigation summary: 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 conn o/o sd top ntch 5.5x5.5 t was found the rod burr.The misalignment can be related with the burr identified.No other defect was found.A dimensional inspection for the conn o/o sd top ntch 5.5x5.5 t was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.A functional test could not be performed as the device was found damage 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 conn o/o sd top ntch 5.5x5.5 t 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? yes, reviewed.Dimensional inspection: n/a.Device history a review of the receiving inspection (ri) for conn o/o sd top ntch 5.5x5.5 t was conducted identifying.That lot number nw278808 was released in two batch.(b)(4).Supplier: norwood medical.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 synthes reports an event in japan as follows: it was reported that on (b)(6) 2022, a revision surgery was performed due to rod breakage.During the surgery, rods were added from two to four.While applying the rods to the universal connector, the rods were not parallel to each other, and the rods were forcefully inserted into the connector at a slight angle.After tightening the set screw with a screwdriver, the surgeon felt discomfort during final tightening and loosened the set screw.Then, it was found that the set screw thread got stripped.The surgeon confirmed that there were no metal fragments in the patient¿s body.A new connector was used, and the rods were bent to re-arrange the rod array.The surgery was completed successfully with 30 minutes delay.No further information is available.This pc is related to pc-001248342 which reports that rod broke after the primary surgery.This pc reports that attaching failure occurred during the revision surgery this report involves one unknown locking/set screws.This is report 3 of 3 for (b)(4).

• Brand Name: CONN O/O SD TOP NTCH 5.5X5.5 T
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 16436657
• Report Number: 1526439-2023-00340
• Device Sequence Number: 7250336
• Product Code: MNH
• UDI-Device Identifier: 10705034077819
• UDI-Public: (01)10705034077819
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160904
• 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: 179771555
• Device Catalogue Number: 179771555
• Device Lot Number: NW278808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown