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

Model Number	48393001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Status and location of the device is unknown.
Event or Problem Description
It was reported that during placement of a cage with an avs navigator straight inserter, the inserter tip 'broke' off following two hammer blows.The cage and inserter tip were removed and changed without difficulty or adverse consequences to the patient.The procedure was completed successfully with a 10 minute delay to surgery.
Event or Problem Description
It was reported that during placement of a cage with an avs navigator straight inserter, the inserter tip 'broke' off following two hammer blows.The cage and inserter tip were removed and changed without difficulty or adverse consequences to the patient.The procedure was completed successfully with a 10 minute delay to surgery.
Additional Manufacturer Narrative
Visual, dimensional and functional analysis could not be performed as the device was not returned.Device and complaint history records could not be reviewed as a valid lot code was not provided and could not be obtained.The customer reported event could not be confirmed as the device was not available for investigation.It was reported that during impaction of the cage into the disc space, the 'holding system' broke.Through correspondence with the rep, it was reported that the avs navigator inserter fractured at the tip after using a hammer for impaction.As the device was not available for investigation, the specific failure mode could not be confirmed, and a cause could not be determined conclusively.

• 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: 11740963
• Report Number: 0009617544-2021-00071
• Device Sequence Number: 3765236
• Product Code: LXH
• UDI-Device Identifier: 07613327096194
• UDI-Public: 07613327096194
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/09/2021
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1