MAUDE Adverse Event Report: DEPUY SPINE INC NAV DRILL GUIDE BODY 2.8-3.2MM; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	202000123
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a brainlab navigated case using expedium 5.5 kit and symphony navigated 3.2 drill guide, four screws were placed in the patient.Two went in without complication, the second two took longer and surgeon wasn¿t happy that the placement was accurate.With the brainlab rep, each item's calibration was checked.It was the noted that although the drill guide was still visible to the navigation system, it was not accurate by at least couple of mm.On further examination, the array had shifted slightly on the instrument.Following a discussion with surgeon, it was decided in future to check with the scrub team and rep to ensure the instrument is still aligned between each use.Surgeon chose to remove the screws and continue with an uninstrumented fusion.The surgery was prolonged by one hour extra.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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
Additional information received states that there was no allegation against the expedium 5.5 kit or two screws.The patient was discharged one day post op with routine planned 2-3 month review with surgeon.
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.H11 additional narrative: added: b5, d10 (concomitant).Corrected: e1 (initial reporter first name, last name).H3, h6: product was not returned.Based on the information available, it has been determined that no corrective and 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 if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: NAV DRILL GUIDE BODY 2.8-3.2MM
• Common Device Name: GUIDE, SURGICAL, 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: 21266596
• Report Number: 1526439-2025-00134
• Device Sequence Number: 8451343
• Product Code: FZX
• UDI-Device Identifier: 10705034530451
• UDI-Public: (01)10705034530451
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K191943
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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: 202000123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 02/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: DRILL GUIDE MODULAR HANDLE; NAV 3.2MM DRILL FOR 4.5MM SCRW; NAV ARRAY ORANGE 3; NAV RING SIZE 12; UNKNOWN KITS/SETS; UNKNOWN SCREWS; UNKNOWN SCREWS; UNKNOWN SCREWS; UNKNOWN SCREWS; UNKNOWN SCREWS; UNKNOWN SCREWS; UNKNOWN SCREWS
• Patient Sex: Unknown