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

Catalog Number	48930000
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/19/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the steerable inserter would not articulate in surgery.There were no adverse consequences as a result of this event, the procedure was completed successfully by using a straight inserter, and there was a surgical delay of 1 minute due to identification of the matter prior to inserting the implant.
Event or Problem Description
It was reported that the steerable inserter would not articulate in surgery.There were no adverse consequences as a result of this event, the procedure was completed successfully by using a straight inserter, and there was a surgical delay of 1 minute due to identification of the matter prior to inserting the implant.
Additional Manufacturer Narrative
Method: product inspection, product history review, complaint history review, labelling review, risk assessment.Result: the reported event of confirmed via functional inspection.Upon functional inspection, the black knob was grinding during rotation.There was confirmed red rust discoloration.When the black knob was rotated too far, it would appear to be stuck.Post-lubrication, the device worked as intended.Manufacturing records were reviewed and no relevant manufacturing issues were identified.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 potential root cause of this investigation appears to be related to lack of lubrication.
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.
Event or Problem Description
It was reported that the steerable inserter would not articulate in surgery.There were no adverse consequences as a result of this event, the procedure was completed successfully by using a straight inserter, and there was a surgical delay of 1 minute due to identification of the matter prior to inserting the implant.

• 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: 7789692
• Report Number: 0009617544-2018-00194
• Device Sequence Number: 1909316
• Product Code: LXH
• UDI-Device Identifier: 07613327370096
• UDI-Public: 07613327370096
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 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: 48930000
• Device Lot Number: 17C621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2018
• Initial Date Received by Manufacturer: 07/19/2018
• Supplement Date Received by Manufacturer: 09/12/2018; 10/28/2018
• Initial Report FDA Received Date: 08/16/2018
• Supplement Report FDA Received Date: 10/11/2018; 11/21/2018
• 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