MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM SPINE SYSTEM POLYAXIAL SCREW 5.5 X 8 X 80MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number	179712880
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery on (b)(6) 2024, the t20 screwdriver tip snapped off inside the screw.This caused issues removing the screw as the screw was not fully inserted.The polyaxial head then popped off when trying to remove the screw, and the screw was removed by a mole grip wrench.Another screw was inserted, and the surgery was completed.The surgery was extended by approximately 60 minutes while trying various ways to remove the screw from the patient.The operation was required to be completed using alternative methods.There was no injury to the patient.This report involves one expedium spine system polyaxial screw 5.5 x 8 x 80mm.This is report 2 of 2 for (b)(4).
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.H11 additional narrative: d4: udi: the manufacturing date is currently not available.Therefore, the full udi is currently not available.D2b: additional device product codes: kwq, mni, mnh, kwp.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.
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.H3, h6: an analysis of the product could not be performed since a physical sample was not received for evaluation.The ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.Device history review (dhr): a review of the receiving inspection (ri) for exp ti poly screw 8mmx80mm was conducted identifying that lot number rl268945 released in one batch.Batch1: lot qty of (b)(4) units were released may 29, 2018 with no discrepancies.Supplier: (b)(4).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.

• Brand Name: EXPEDIUM SPINE SYSTEM POLYAXIAL SCREW 5.5 X 8 X 80MM
• 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
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 19996674
• Report Number: 1526439-2024-02067
• Device Sequence Number: 18250825
• Product Code: NKB
• UDI-Device Identifier: 10705034068145
• UDI-Public: (01)10705034068145(10)RL268945
• Combination Product (Y/N): N
• 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: Other Health Care Professional
• Type of Report: Initial,Followup

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 Catalogue Number: 179712880
• Device Lot Number: RL268945
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/18/2024
• Supplement Date Received by Manufacturer: 08/31/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: XPDM QUICK-CON SI POLY SCWDRVR.
• Patient Sex: Unknown