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

Model Number	48921100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hospital disposed of device.
Event or Problem Description
It was reported that the tip of the aero al inserter inner shaft fractured into the aero al cage during implant insertion.The tip of the inner shaft was left in the cage.The procedure was completed successfully with an unknown amount of surgical delay.No adverse consequences nor medical intervention were reported.This record captures the aero al inserter inner shaft.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.Complaint history records were reviewed for this catalog number, no similar complaints were identified.It was reported that the tip of the aero al inserter inner shaft fractured into the aero al cage during implant insertion.The tip of the inner shaft was left in the cage.The procedure was completed successfully with an unknown amount of surgical delay.No adverse consequences nor medical intervention were reported.Three (3) follow up attempts were performed to obtain additional information, but no response was received.The aero al anterior lumbar interbody and fixation system surgical technique and device ifu were reviewed: ¿impact the proximal end of the impaction handle using the mallet to safely and gradually insert the implant.The implant is fully implanted when the depth stops on the inserter guide make contact with the anterior aspects of both the superior and inferior vertebral bodies." note: ¿to reduce the risks of breakage, care must be taken not to distort the implants or nick, hit or score them with the instruments unless otherwise specified by the applicable stryker spine surgical technique.Instruments should be examined for wear or damage by doctors and staff in operating centers prior to surgery." due to lack of information and device not returned, an exact cause of the reported event could not be determined.Potential causes include: normal wear due to age of device/ extensive use or too much cantilever force applied during cage insertion.
Event or Problem Description
It was reported that the tip of the aero al inserter inner shaft fractured into the aero al cage during implant insertion.The tip of the inner shaft was left in the cage.The procedure was completed successfully with an unknown amount of surgical delay.No adverse consequences nor medical intervention were reported.This record captures the aero al inserter inner shaft.

• 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
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 12962536
• Report Number: 0009617544-2021-00229
• Device Sequence Number: 19296537
• Product Code: LXH
• UDI-Device Identifier: 07613327273496
• UDI-Public: 07613327273496
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2022

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: 48921100
• Device Catalogue Number: 48921100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2021
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 03/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown