MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM SPINE SYSTEM SI POLYAXIAL EXTEND TAB 5.5 X 7.0 X 45MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	179732745
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/01/2022
Type of Reportable Event	Serious Injury
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 device product codes: kwp, mnh, kwq, osh, and mni.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.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.
Event or Problem Description
Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2022, the patient underwent a revision procedure, lumbar spinal fusion.After removing a screw, the surgeon moved on to inserting a cfs 8mm screw with the screwdriver.Then, the screwdriver¿s tip broke off.The fragmented tip was immovable in the screw¿s shank and has been left in the lesion.This report involves one (1) expedium spine system si polyaxial extend tab 5.5 x 7.0 x 45mm.This is report 2 of 2 for (b)(4).

• Brand Name: EXPEDIUM SPINE SYSTEM SI POLYAXIAL EXTEND TAB 5.5 X 7.0 X 45MM
• 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 Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 15140685
• Report Number: 1526439-2022-01317
• Device Sequence Number: 7330315
• Product Code: NKB
• UDI-Device Identifier: 10705034074047
• UDI-Public: (01)10705034074047
• 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: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 179732745
• Device Catalogue Number: 179732745
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 08/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: UNKNOWN SCREWS; XPDM QUICK-CON SI POLY SCWDRVR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown