MAUDE Adverse Event Report: DEPUY SPINE INC EXPEDIUM VERSE SLEEVE NAVIGATION ENABLED INSTRUMENTS; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	301019041
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2023, the instruments in question were found to be unfit for surgery during sterile processing of incoming field inspection.A borescope was run down the cannulated instruments and found that they fell outside of the guidelines for use in surgery.There was no reported patient interaction, however a scheduled case had to be cancelled as the proper tooling was unavailable.No further information is available.This report is for an expedium verse sleeve navigation enabled instruments.This is report 2 of 8 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: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.H3, h6: 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.
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.H10 additional narrative: a review of the receiving inspection (ri) for verse sleeve, was conducted identifying that lot number pu174311 was released in one batch batch1: lot qty of (b)(4).Units were released on 16 feb, 2022 with no discrepancies.Supplier: (b)(4).As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.The product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that inner portion of the 301019041, verse sleeve shows signs of foreign substance.The observed condition is likely due to improper cleaning/sterilization.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the 301019041, verse sleeve would contribute to the complained device issue.Based on the investigation findings, potential cause can be traced to maintenance and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.If information is obtained that was not available for this 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.H6: the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the verse sleeve has a foreign stains over the surface.No other issues were observed.The observed condition is most likely due to improper cleaning/sterilization process.A dimensional inspection was not performed as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the verse sleeve would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Drawing/specifications reviewed dwg 103596290 rev a current & manufactured.Dimensional inspection: n/a.H6: a review of the receiving inspection (ri) for verse sleeve was conducted identifying that lot number pu174311 was released in one batch.Batch 1: lot units were released on 16 feb 2022 with no discrepancies.Supplier: (b)(4).As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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: EXPEDIUM VERSE SLEEVE NAVIGATION ENABLED INSTRUMENTS
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 18103774
• Report Number: 1526439-2023-02284
• Device Sequence Number: 6004189
• Product Code: OLO
• UDI-Device Identifier: 10705034561677
• UDI-Public: (01)10705034561677
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K200791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup

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 Catalogue Number: 301019041
• Device Lot Number: PU174311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/23/2023
• Supplement Date Received by Manufacturer: 11/15/2023; 02/12/2024
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 12/06/2023; 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRENCH ROD BENDER; VERSE KEY INSERTER TIGHTENER; VERSE SLEEVE; VERSE SLEEVE; VERSE SLEEVE; VERSE SLEEVE; VERSE X25 INSERTER/TIGHTENER; VERSE X25 INSERTER/TIGHTENER
• Patient Sex: Unknown