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	12/20/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; or manager at the clinic, reported the following event to , sales rep : "arthrodesis procedure, patient operated by doctor.Installation and positioning of the patient was performed.While preparing the pedicle sight with jam shidi trocar, he 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
Method: visual inspection, material analysis, device history review, complaint history review, risk assessment; result: the customer reported event was confirmed via visual inspection.The inner collar was found to be fractured.The fractured pieces were not returned.Manufacturing history was reviewed and no issues were identified.Upon material analysis of the returned device, it was concluded that the ratchet handle was fractured in a mixed mode of cleavage and ductile due to an applied torsional force while contacting an implant.The measured hardness and elemental composition met the requirements specified on the print.No material or manufacturing defects were found.Conclusion: the root cause of the reported event could not be determined conclusively but potential root causes include: - excessive torsional force applied by user - excess force applied to screwdriver (cantilever) - screw not properly aligned with screwdriver.
Event or Problem Description
It was reported that; or manager at the clinic, reported the following event to , sales rep : "arthrodesis procedure, patient operated by doctor.Installation and positioning of the patient was performed.While preparing the pedicle sight with jam shidi trocar, he 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: 7199459
• Report Number: 0009617544-2018-00013
• Device Sequence Number: 1044316
• 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): 06/04/2018

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: 173904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Initial Date Received by Manufacturer: 12/21/2017
• Supplement Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 01/17/2018
• Supplement Report FDA Received Date: 06/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1