MAUDE Adverse Event Report: STRYKER SPINE-US REFLEX-HYBRID PLATE HOLDER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48510300
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that the tip of a reflex hybrid revision driver draw rod screw extractor fractured when removing a screw from the plate and the reflex hybrid plate holder is, "coming apart." the procedure was completed successfully with no surgical delay and no adverse consequence to the patient.This report captures the reflex hybrid plate holder.
Event or Problem Description
A company representative reported that the tip of a reflex hybrid revision driver draw rod screw extractor fractured when removing a screw from the plate and the reflex hybrid plate holder is, "coming apart." the procedure was completed successfully with no surgical delay and no adverse consequence to the patient.This report captures the reflex hybrid plate holder.
Additional Manufacturer Narrative
Additional information: d4, d9, h3 have been updated to reflect receipt of the device and device lot number.
Event or Problem Description
A company representative reported that the tip of a reflex hybrid revision driver draw rod screw extractor fractured when removing a screw from the plate and the reflex hybrid plate holder is, "coming apart." the procedure was completed successfully with no surgical delay and no adverse consequence to the patient.This report captures the reflex hybrid plate holder.
Additional Manufacturer Narrative
A visual inspection was performed on the device and the reported issue was confirmed, whereby it was found that the tip of the device does not close uniformly as one prong remains longer than the other.Wear around the laser marking and on the body of the device was identified.The device is no longer functional as it cannot hold the plate as intended.Device history records were reviewed for the corresponding lot and no relevant issues were identified.A review of complaint history associated with the subject catalog number was performed, and no adverse trends were observed.It was initially reported that the tip of a reflex-hybrid plate holder was not closing as it supposed to.The cause of the device mechanism coming apart is normal wear and tear due to device age.Per the surgical technique: the life of the instrument depends on the number of times they are used as well as the precautions taken in handling, cleaning and storage.Great care must be taken of the instruments to ensure that they remain in good working order.

• Brand Name: REFLEX-HYBRID PLATE HOLDER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 13763153
• Report Number: 0009617544-2022-00030
• Device Sequence Number: 2519335
• Product Code: LXH
• UDI-Device Identifier: 07613327270747
• UDI-Public: 07613327270747
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/15/2022

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: 48510300
• Device Catalogue Number: 48510300
• Device Lot Number: 072703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/15/2022
• Supplement Date Received by Manufacturer: 03/21/2022; 05/17/2022
• Initial Report FDA Received Date: 03/14/2022
• Supplement Report FDA Received Date: 04/19/2022; 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2007
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown