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

Catalog Number	48930000
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the steerable inserter's black knob got stuck.Additionally, while attempting to rotate the implant on the inserter, it rotated initially and then got stuck.This event occurred during device inspection, prior to the planned surgical procedure.The procedure was rescheduled for the following day, and was completed successfully using a pl cage.
Additional Manufacturer Narrative
Method: product inspection, product history review, complaint history review, nc/capa history review, labelling review, risk assessment result: the reported event could not be confirmed.The returned device was inspected.The draw rod was confirmed to be jammed inside the inserter however, the black knob jamming could not be confirmed.Since the draw rod was stuck inside the inserter, the black knob mechanism could not be tested.The steering tip of the inserter was also disassembled and black knob was removed from instrument to allow for viewing of mechanism.Draw rod was later removed utilizing the surgical technique guide instructions and as the inserter had already been taken apart, confirmation of the failure was still unable to be tested for.Manufacturing records were reviewed and no relevant manufacturing issues were identified.It was determined that the lot was manufactured approximately 5 months ago.Surgical technique states:" instruments must be examined for wear or damage prior to surgery.Thoroughly inspect the inserter tip and inserter shaft for any damage prior to use and do not use if any damage is evident to threads, rotating mechanism, etc." conclusion: the exact root cause of draw rod jamming could not be determined.Remedial action: stryker has decided to take a field action specifically, stryker executed a correction as there was no product removal required.
Event or Problem Description
It was reported that the steerable inserter's black knob got stuck.Additionally, while attempting to rotate the implant on the inserter, it rotated initially and then got stuck.This event occurred during device inspection, prior to the planned surgical procedure.The procedure was rescheduled for the following day, and was completed successfully using a pl cage.
Event or Problem Description
It was reported that the steerable inserter's black knob got stuck.Additionally, while attempting to rotate the implant on the inserter, it rotated initially and then got stuck.This event occurred during device inspection, prior to the planned surgical procedure.The procedure was rescheduled for the following day, and was completed successfully using a pl cage.
Additional Manufacturer Narrative
Applicable stryker personnel that are involved in the maintenance or preparation of the tritanium tl inserter have been identified to receive notification of a correction to assure that the instrument is lubricated adequately.The stryker personnel includes stryker representatives that handle and review instrumentation prior to each surgery as well as personnel responsible for preparing loaner sets for distribution to the field.

• 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: 7791064
• Report Number: 0009617544-2018-00197
• Device Sequence Number: 1195488
• Product Code: LXH
• UDI-Device Identifier: 07613327370096
• UDI-Public: 07613327370096
• Combination Product (Y/N): N
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/17/2019

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: 48930000
• Device Lot Number: 17C621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Initial Date Received by Manufacturer: 07/25/2018
• Supplement Date Received by Manufacturer: 09/12/2018; 12/20/2018
• Initial Report FDA Received Date: 08/16/2018
• Supplement Report FDA Received Date: 10/11/2018; 01/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3004024955-9/12/18-001-C
• Patient Sequence Number: 1