MAUDE Adverse Event Report: STRYKER SPINE-US MANTIS LONG CONSTRUCT 110 DEG ROD INSERTER METAL; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	48480111
Medical Device Problem Codes	Material Separation (1562); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Status and location of the device is currently unknown.
Event or Problem Description
It was reported that a mantis long construct 110 deg rod inserter metal tip disengaged intraoperatively.There were no adverse consequences to the patient.
Event or Problem Description
It was reported that a mantis long construct 110 deg rod inserter metal tip disengaged intra-operatively.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Visual inspection: visual inspection confirmed that tip of the returned inserter is missing.The hex tip was confirmed to be separated from the anvil.Weld analysis was performed and a fillet weld was present as specified on the drawing.Eds analysis on the anvil and hex tip both met the specification on the print.No material or manufacturing defects were found.Material analysis on similar device for similar complaint was performed.Device and complaint history records were reviewed for lot # 10h223.No relevant manufacturing issues were identified as all units met stryker specifications and no similar complaints were identified.Upon dhr review, the instrument was found to be more than seven years old.Per email correspondence with the company representative in the field, the instrument was used very often.The general instrument ifu states that: 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.The possible root cause of this event is normal wear and tear of the instruments.The possible root cause of this event is normal wear and tear of the instruments.

• Brand Name: MANTIS LONG CONSTRUCT 110 DEG ROD INSERTER METAL
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9372925
• Report Number: 0009617544-2019-00125
• Device Sequence Number: 19404893
• Product Code: LXH
• UDI-Device Identifier: 07613327270815
• UDI-Public: 07613327270815
• Combination Product (Y/N): N
• PMA/510(K) Number: K133188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2020

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: 48480111
• Device Catalogue Number: 48480111
• Device Lot Number: 10H223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Initial Date Received by Manufacturer: 11/04/2019
• Supplement Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 01/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1