MAUDE Adverse Event Report: STRYKER SPINE-US INSERTER TRITANIUM TL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48930000
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during intra-operative implant insertion a tritanium tl inserter would not release the cage.There were no adverse consequences to the patient.The procedure was completed successfully with a 60 minute surgical delay.
Additional Manufacturer Narrative
H3 has been corrected to reflect the unknown location status of the device.Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records were reviewed for this lot, no relevant manufacturing issues or similar complaints were identified.No additional information or products were received regarding the event.The initial report states that the implant was unable to be disengaged from the inserter once turned in the disc space.So the entire system was then removed from the patient.However, the inserter shaft was unable to be removed from the inserter.Additionally, the inserter driver (insertion removal tool), which is used to disengage the inserter shaft from the inserter, was unable to be removed from the inserter shaft when attempting to disengage the inserter shaft from inserter.Some potential root causes of this event include: user does not rigidly lock inserter during use, -inserter pivot joint or locking system is previously damaged or worn prior to use, -implant rotated prior to use of half saddle tamp.Threaded pivot head of inner shaft not aligned with axis of inner shaft.Decompression tubes not correctly aligned with entry.Decompression tube dislodges due to too much impaction force.Tamp too large for decompression tube.Incorrect geometry between tamp and implant surface.Tamp damaged prior to use.Unable to visualize tamp/implant connection.Inserter inner shaft/rod may be previously bent or deformed, -insufficient visibility of inner shaft/rod to insertion handle.Insufficient lubrication on inserter/draw rod prior to use.Instrument not lubricated.However, due to no additional information or product return, the root cause could not be determined conclusively.H3 other text : status and location of the device is unknown.
Event or Problem Description
It was reported that during intra-operative implant insertion a tritanium tl inserter would not release the cage.There were no adverse consequences to the patient.The procedure was completed successfully with a 60 minute surgical delay.

• Brand Name: INSERTER TRITANIUM TL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11904300
• Report Number: 0009617544-2021-00100
• Device Sequence Number: 17056023
• Product Code: LXH
• UDI-Device Identifier: 07613327370096
• UDI-Public: 07613327370096
• 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: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2021

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: 48930000
• Device Catalogue Number: 48930000
• Device Lot Number: 188081
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 05/28/2021
• Supplement Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1