MAUDE Adverse Event Report: DEPUY SPINE INC PRIME STYLET DEPTH ADJUSTOR; ORTHOPAEDIC STEREOTAXIC INSTRUMENT

Model Number	286750041
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes 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.
Event or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2021 that the nurse wanted to remove the prime stylet depth adjustor from the screwdriver to adapt the stylet depth.While removing it, it got stuck in the t-handle.It was not possible to remove either of the articles from the screwdriver.The depth adjuster was pushed back with a hammer and the t-handle was removed.The height was the able to be adjusted.There was a two (2) minute surgical delay and the procedure was completed successfully.Concomitant device: unknown screwdriver (part# unknown, lot# unknown, quantity unknown).This report is for one (1) prime stylet depth adjustor.This is report 2 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: investigation summary.Photo investigation: the device was not returned.A photo-investigation was performed on the image provided.Upon inspecting the images provided, the head of the viper prime stylet depth adjustor can be seen sticking out through the hole of the viper prime t-handle.However, the complaint allegation of the two devices being stuck together cannot be confirmed from the provided images.The root cause for the reported event cannot be determined from the available 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.Only the viper prime t-handle was returned and has been investigated separately under (b)(6).Conclusion: the complaint condition cannot be confirmed during photo investigation.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.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: PRIME STYLET DEPTH ADJUSTOR
• Common Device Name: ORTHOPAEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12174491
• Report Number: 1526439-2021-01411
• Device Sequence Number: 13860951
• Product Code: OLO
• UDI-Device Identifier: 10705034507644
• UDI-Public: 10705034507644
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K170937
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 286750041
• Device Catalogue Number: 286750041
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/16/2021
• Supplement Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SCREWDRIVERS.; VIPER PRIME T-HANDLE.; UNKNOWN SCREWDRIVERS; VIPER PRIME T-HANDLE