MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SINGLE-INNER SETSCREW; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number 179702000

Device Problem Device-Device Incompatibility (2919)

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

Event Date 08/11/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Additional product code: kwp; kwq; mnh; mni; osh.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 Description

It was reported that on (b)(6) 2021, during spinal fusion surgery the surgeon was instrumenting an one-level lumbar fusion with expedium.During set screws placement, the surgeon was having difficulty engaging the set screws to the tulip on the polyaxial head.There was a surgical delay of five (5) minutes.There were no patient consequences.The procedure was successfully completed.Concomitant device reported.Unknown screwdriver (part # unknown, lot # unknown, qty 1).This complaint involves six (6) devices.This report is for (1) single-inner set screw.This report is 3 of 6 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.H3, h6: part # 179702000.Lot # 289082.Supplier: (b)(4).Batch # 1 qty (b)(4) release to warehouse date february 11, 2021.Batch #2 qty (b)(4) release to warehouse date july 7, 2021.No ncr's were generated during production.Visual inspection: the single-inner setscrew (pn: 179702000, ln: 289082) was sent to jabil: le locle for investigation.Upon visual inspection, it was noticed a deformation of the hexlobes.The hexlobe corners have been deformed which resulted in overthickness of the set screw internal diameter.Visual inspection of the external thread showed presence of bright areas on the surface which indicated that the matte finish was removed.The bright areas showed that this defect appeared after the matte finish operation performed during the sandblasting phase according to procedure de sablage.Visual inspection of the internal thread diameter shows a deformation on the first thread.The overall deformation was found to be post-manufacturing.Functional test: assembly inspection- mating part inspection: expedium head.The setscrew was inserted in the head thread and it was found to be conform despite the physical post manufacturing deformation.Can the complaint be replicated with the returned device? deformation of the device was noticed from the visual inspection.Dimensional inspection: inspections have been performed to ensure the conformity of set screws: inspection checklist.Part conformed to drawing specification except two criteria that were out of specification.External diameter for the set screw.Internal diameter for the set screw.Devices: micrometer.Cylindrical gage.Go nogo gauge.Complaint confirmed? yes.Conclusion: the complaint condition was confirmed for the set screw as the visual inspection revealed deformation of the device and also the dimensional inspection revealed an out of specification on two features.During the investigation, it was also revealed that the damage sustained by the set screw was post manufacturing and occurred likely during the surgery.No product design issues or discrepancies were observed.Based on the investigation, the manufacturing process at jabil le locle has been performed according to the applicable procedures without any issue.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.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: SINGLE-INNER SETSCREW
• Type of Device: 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 ; SZ
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle, MA ; SZ ; 6103142063
• MDR Report Key: 12441296
• MDR Text Key: 270824891
• Report Number: 1526439-2021-01881
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034064307
• UDI-Public: 10705034064307
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 179702000
• Device Catalogue Number: 179702000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/11/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW; UNKNOWN SCREWDRIVERS; UNKNOWN SCREWS; UNKNOWN SCREWS; UNKNOWN SCREWS