MAUDE Adverse Event Report: STRYKER SPINE-US MANTIS REDUX ROUND HANDLE NON RATCHET; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Catalog Number	48289305
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/03/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: arthrodesis procedure, patient operated.Installation and positioning of the patient.Preparing the pedicle sight with jam shidi trocar.When the doctor wanted to implant the screw through the pedicle with the screwdriver, the handle broke at the rack.He had to use another handle to complete the procedure.There was a delay of about 5-10 minutes.
Additional Manufacturer Narrative
Visual inspection, device history review, complaint history review, risk assessment.Result: the customer reported event was confirmed via visual inspection.The device was confirmed to be fractured at inner collar on both sides.Manufacturing history was reviewed and no issues were identified.Age of the instrument was found to be approximately 6 years old.Conclusion: the most likely cause of the reported event was determined to be normal wear due to instrument age.
Event or Problem Description
It was reported that: arthrodesis procedure, patient operated.Installation and positioning of the patient.Preparing the pedicle sight with jam shidi trocar.When the doctor wanted to implant the screw through the pedicle with the screwdriver, the handle broke at the rack.He had to use another handle to complete the procedure.There was a delay of about 5-10 minutes.

• Brand Name: MANTIS REDUX ROUND HANDLE NON RATCHET
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7220397
• Report Number: 0009617544-2018-00020
• Device Sequence Number: 16617014
• Product Code: LXH
• UDI-Device Identifier: 07613327266948
• UDI-Public: (01)07613327266948
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nursing Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2018

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: No Information
• Device Catalogue Number: 48289305
• Device Lot Number: 128570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Initial Date Received by Manufacturer: 01/04/2018
• Supplement Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 01/25/2018
• Supplement Report FDA Received Date: 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1