MAUDE Adverse Event Report: STRYKER SPINE-US NAVIGATOR STRAIGHT INSERTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48393001
Medical Device Problem Codes	Material Separation (1562); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the securing mechanism of an avs navigator straight inserter disengaged during intra-operative implant placement.The procedure was completed successfully using an alternative instrument.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Corrected data: d.2.Common device name has been updated from 'intervertebral fusion device with bone graft, lumbar' to 'orthopedic manual surgical instrument' d.9 was update to reflect product return.Upon visual inspection of the returned device, it was confirmed that the tip of the inserter was deformed.The two legs of the clasping mechanism (inserter track) were splayed outwards which can compromise a secure fit on the implant, leading to premature disengagement.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.As this device was manufactured in 2017, it is likely that repeated use of the device throughout its service life could have contributed to tip deformation.
Event or Problem Description
It was reported that the securing mechanism of an avs navigator straight inserter disengaged during intra-operative implant placement.The procedure was completed successfully using an alternative instrument.No adverse consequences or medical intervention were reported.

• Brand Name: NAVIGATOR STRAIGHT INSERTER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10246787
• Report Number: 0009617544-2020-00118
• Device Sequence Number: 535825
• Product Code: LXH
• UDI-Device Identifier: 07613327096194
• UDI-Public: 07613327096194
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2020

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: 48393001
• Device Catalogue Number: 48393001
• Device Lot Number: 16A822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 07/08/2020
• Supplement Report FDA Received Date: 08/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1