MAUDE Adverse Event Report: STRYKER SPINE-US AERO AL INSERTER GUIDE INNER SHAFT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Catalog Number	48921100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the scrub tech loaded a 15 cage onto a 19 inserter and as a result, the pressure from tamping an anchor in broke 2 inserter guide pin.No adverse consequences to the patient is reported.
Additional Manufacturer Narrative
Method: labelling review, risk assessment.Result: the customer reported event was confirmed via correspondence.All broken fragments were disposed properly.Plate and screw was successfully implanted.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Conclusion: based on the information available, the inserter used has the wrong size related to the implanted cage.This is a deviation from what surgical technique suggests.Therefore, the root cause is the deviation from surgical technique ¿ the usage of a wrong size inserter during the cage implantation.
Event or Problem Description
It was reported that the scrub tech loaded a 15 cage onto a 19 inserter and as a result the pressure from tamping an anchor in broke 2 inserter guide pin.No adverse consequences to the patient is reported.

• Brand Name: AERO AL INSERTER GUIDE INNER SHAFT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7898484
• Report Number: 0009617544-2018-00226
• Device Sequence Number: 13866480
• Product Code: LXH
• UDI-Device Identifier: 07613327273496
• UDI-Public: 07613327273496
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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): 11/21/2018

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: 48921100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 09/21/2018
• Supplement Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1