MAUDE Adverse Event Report: SYNTHES GMBH 4.5MM TI CANCELLOUS POLYAXIAL SCREW 30MM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	04.614.230
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from depuy synthes reports an event in canada as follows: it was reported that during a cervical spine fusion case using the synapse system, upon inserting a 4.5mm x 30mm screw in the t1 level, the head of the screw broke off.No lot # was identified on the screw.No patient or other information is available.Unknown if fragments were generated.Surgery was delayed 20 minutes due to the reported event.Concomitant device reported: unk - insertion instruments: trauma (part# unknown; lot# unknown; quantity: unknown).This complaint involves one (1) device.This report is for one (1) 4.5mm ti cancellous polyaxial screw 30mm.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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 pro-codes: nkg, mnh, mni.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.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.
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.H6: clinical code added for foreign body in patient.Medical device problem codes updated.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
The screw was placed in patient's vertebrae, broke on standard application.The surgeon removed pieces, but some pieces remained post op.

• Brand Name: 4.5MM TI CANCELLOUS POLYAXIAL SCREW 30MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15965945
• Report Number: 8030965-2022-10947
• Device Sequence Number: 5573967
• Product Code: KWP
• UDI-Device Identifier: 10705034738864
• UDI-Public: (01)10705034738864
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142838
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.614.230
• Device Catalogue Number: 04.614.230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2022
• Supplement Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 01/06/2023
• 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: UNK - INSERTION INSTRUMENTS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown