MAUDE Adverse Event Report: DEPUY SPINE INC SI POLYAXL SCREW 7 X 45MM; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number	179712745
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code: mnh, nkb, kwq, kwp, osh.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that, procedure was revised due to back pain and connection degeneration.This report is for one (1) si polyaxl screw 7 x 45mm.This is report 1 of 7 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.H3, h6: investigation summary: the complaint device was not received for investigation.A photo investigation was performed based on the images received.The images were reviewed and the complaint condition is not confirmed.The poly axial screw does not appear to have any damage or manufacturing defects that would contribute to the complaint condition.A definitive assignable root cause could not be determined based on the provided information.As the device was not returned, an as-received condition could not be assessed and a dimensional inspection and document/specification review were not completed.During the investigation, no product design issues or discrepancies were observed (based on the image) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot : the dhr of product code: 179712745.Lot : arnbc4.Was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: 05.11.2014.Qty: (b)(4).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.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.H6: corrected investigation findings and conclusion code.
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.H10 additional narrative: d6a; d9; h4 h3, h6: a product investigation was conducted.Visual inspection: the complaint device si polyaxl screw 7 x 45mm (product code: 179712745, lot number: arnbc4) was returned to cq west chester for investigation.The screw was returned broken in two parts the head and the threaded screw shaft with the round portion of screw inside the head.The threaded portion of the screw was stripped and the violet color fading off from the shaft.Document /specification review: based on the date of manufacture, the current and manufactured version of the drawings were reviewed.Dimensional inspection: complaint relevant dimension could not be measured due to post manufacturing damage.Conclusion: the screw had broken into two pieces during surgery.This could have been caused by excessive pressure applied during procedure.A definitive root cause was not determined during investigation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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.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.G2; g4.

• Brand Name: SI POLYAXL SCREW 7 X 45MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): SENTIO (INNOVATIVE SURGICAL SOLUTIONS, LLC); 50461 west pontiac trail; wixom MI 48393
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12961907
• Report Number: 1526439-2021-02512
• Device Sequence Number: 1751169
• Product Code: MNI
• UDI-Device Identifier: 10705034067902
• UDI-Public: (01)10705034067902
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/09/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 179712745
• Device Catalogue Number: 179712745
• Device Lot Number: ARNBC4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2021
• Supplement Date Received by Manufacturer: 12/13/2021; 01/05/2022; 02/04/2022
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 12/28/2021; 02/03/2022; 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2014
• 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: 5.5 TI CORT FIX 7X40MM; SI POLYAXL SCREW 7 X 45MM; SI POLYAXL SCREW 7 X 50MM; UNKNOWN CAGE/SPACER; UNKNOWN LOCKING/SET SCREWS; UNKNOWN RODS; UNKNOWN RODS; UNKNOWN SCREWS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown