MAUDE Adverse Event Report: DEPUY SPINE INC BONE SCREW 5.2MMX 21MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	187155021
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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
It was reported that on (b)(6) 2021, the patient underwent revision surgery due to two (2) 21mm lower screws breaking who had an aegis plate implanted on (b)(6) 2021, at (b)(6) medical center.It was unknown if the surgery completed successfully.The patient outcome was unknown.Concomitant device reported: unknown plate (part# unknown, lot# unknown, quantity unknown).This complaint involves two (2) devices.This report is for (1) bone screw 5.2mm x 21mm this report is 1 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.H10 additional narrative: h3, h4, h6.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.The complaint condition was not confirmed during photo investigation.No new, unique or different patient harms were identified as a result of this evaluation.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 preventive 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 device lot number is unknown, therefore a mre review could not be performed.If more information become available, the record will be re-assessed.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: BONE SCREW 5.2MMX 21MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11907609
• Report Number: 1526439-2021-01063
• Device Sequence Number: 3328662
• Product Code: KWQ
• UDI-Device Identifier: 10705034136325
• UDI-Public: 10705034136325
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K052546
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2021

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: 187155021
• Device Catalogue Number: 187155021
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 05/31/2021
• Supplement Report FDA Received Date: 06/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN PLATES; UNKNOWN SCREWS; UNKNOWN SCREWS
• Outcome Attributed to Adverse Event: Required Intervention