MAUDE Adverse Event Report: DEPUY SPINE INC SI POLYAXL SCREW 5 X 45MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	179712545
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2021 the patient underwent a lumbar fusion with pedicle screw fixation using the depuy expendium polyaxial synthes screw.The patient experienced severe back pain and it was discovered that the screw had been cut inside the patient.A revision operation was performed on (b)(6) 2021 where part of the screw was removed.The other part of the screw remains inside patient's body.This report is for (1) expedium spine system si polyaxial screw 5.5 x 5 x 45mm.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Investigation summary: visual inspection: the si polyaxl screw 5 x 45mm (p/n: 179712545, lot number: apdbnf) was received at us cq.Visual inspection of the complaint device shows that the shaft of the device was broken and the pc attachment shows the broken embedded device x-ray.Device failure/defect identified? yes.Dimensional inspection: complaint relevant dimensional inspection was not performed due to the geometry of the device.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Complaint confirmed? yes.Investigation conclusion: this complaint could be confirmed.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.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 history lot: the dhr of product code: 179712545; lot : apdbnf; was electronically reviewed and no non-conformances were observed during the manufacturing process; the product was released on: march 13, 2013.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: SI POLYAXL SCREW 5 X 45MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• 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 ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12786882
• Report Number: 1526439-2021-02365
• Device Sequence Number: 14726161
• Product Code: NKB
• UDI-Device Identifier: 10705034067568
• UDI-Public: 10705034067568
• Combination Product (Y/N): N
• Initial Reporter Country: CY
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 179712545
• Device Catalogue Number: 179712545
• Device Lot Number: APDBNF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/15/2021
• Supplement Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 12/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown