MAUDE Adverse Event Report: DEPUY SPINE INC SYMPHONY OCT SYSTEM SHORT DRILL GUIDE ADJUSTABLE BODY; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	202000239
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.D1: symphony oct system short drill guide adjustable body 2.2-2.4mm 0-50mm +/- 0.43 percent d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.H3, h6 investigation summary: 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 on will be updated as applicable.
Event or Problem Description
It was reported that the items were identified as not working during surgery.The set has 2 of each instrument and alternative was used.There was no patient impact.The surgery was successfully completed with no issues.Drill guide body adj 2.2-2.4mm ¿ mechanism broken by one piece lost.Cannot be found.Unable to use during surgery.X15 self retaining inserter - tip damaged and not holding the set screw.

• Brand Name: SYMPHONY OCT SYSTEM SHORT DRILL GUIDE ADJUSTABLE BODY
• 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: 21629927
• Report Number: 1526439-2025-00401
• Device Sequence Number: 15520255
• Product Code: FZX
• UDI-Device Identifier: 10705034530741
• UDI-Public: (01)10705034530741
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• 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

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: 202000239
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2025
• Initial Report FDA Received Date: 03/18/2025
• 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
• Patient Sex: Unknown