MAUDE Adverse Event Report: DEPUY SPINE INC NAV DRILL GUIDE BODY 2.2-2.4MM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	202000120
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2024
Type of Reportable Event	Malfunction
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.D2b: additional product code: fzx d9: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.E1:(b)(6).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.
Event or Problem Description
Device report from synthes reports an event in switzerland as follows: it was reported on january 11, 2024, that the drill sleeve can no longer be assembled because the depth stop is wedged.There were no patient outcome or consequences.This report is for one (1) nav drill guide body 2.2-2.4mm this is report 1 of 1 for complaint (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: h4,h6 a review of the receiving inspection (ri) for nav drill guide body 2.2-2.4mm, was conducted identifying that lot number nn170367 was released in three batches batch1: lot units were released on 20 may,2021 with no discrepancies.Batch2 : lot units were released on 04 nov, 2021 with no discrepancies.Batch 3: lot units were released on 07 dec, 2021 with no discrepancies.Supplier: avalign technologies instruments and implants (nemcomed) 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: NAV DRILL GUIDE BODY 2.2-2.4MM
• 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: 18594823
• Report Number: 1526439-2024-00715
• Device Sequence Number: 8033813
• Product Code: OLO
• UDI-Device Identifier: 10705034530420
• UDI-Public: (01)10705034530420
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Physician
• 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: 202000120
• Device Lot Number: NN170367
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2024
• Supplement Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2021
• 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
• Patient Sex: Unknown