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

Model Number	2020-00-123
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: additional device product codes: olo.Complainant part is not expected to be returned for manufacturer review/investigation.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.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
It was reported that on (b)(6) 2022, one of the instruments in symphony set needed to be replaced.The surgeon noticed that the toothed tip of the symphony drill guide was slightly splayed.Upon inspection, it appeared to be normal wear and tear with no issue or impact on patient care.The tips of the drill guide are splaying out and the drill guide needs to be replaced.The procedure outcome is unknown.This report involves one(1) symphony oct system drill guide adjustable body 2.8-3.2mm 0-50mm +/- 0.33 percent.This is report 1 of 1 for (b)(4).

• Brand Name: NAV DRILL GUIDE BODY 2.8-3.2MM
• Common Device Name: GUIDE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13418070
• Report Number: 1526439-2022-00172
• Device Sequence Number: 14424754
• Product Code: FZX
• UDI-Device Identifier: 10705034530451
• UDI-Public: (01)10705034530451
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: 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 Model Number: 2020-00-123
• Device Catalogue Number: 202000123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 02/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown