MAUDE Adverse Event Report: DEPUY SPINE INC UNKNOWN SCREWS; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2021

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2021, the patient underwent for spinal fusion surgery.The surgeon was performing a posterior cervical fusion with depuy synthes spine symphony.During placement of the rods, the surgeon could not get the instrument to engage the screw without coming off.The instrument is squeezed and engaged; the tips may not be moving enough to capture the screw adequately.The surgery was successfully completed with 3-minutes delay.Not harm or issues with the patient.Concomitant device reported: unknown rods (part# unknown, lot# unknown, quantity unknown).This complaint involves (2) devices.This report is for (1) unknown screws.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unk - unknown screws/unknown lot.Part and lot numbers are unknown; udi number is unknown.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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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: UNKNOWN SCREWS
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): DEPUY SPINE INC ; 325 paramount drive ; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive ; raynham, MA 02767 ; 6107195000
• MDR Report Key: 13101770
• MDR Text Key: 284466525
• Report Number: 1526439-2021-02662
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: REDUCER KERRISON; UNKNOWN RODS