MAUDE Adverse Event Report: STRYKER SPINE-US DECOMPRESSION TUBE SNAKE ARM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48080230
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an lite decompression tube snake arm securing mechanism jammed intra-operatively.The locking knob seized up and would barely rotate.The device will not fully release pressure on the snake arm.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.
Event or Problem Description
It was reported that an lite decompression tube snake arm knob jammed intra-operatively.The locking knob seized up and would barely rotate.The device will not fully release pressure on the snake arm.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.
Additional Manufacturer Narrative
B.5 was updated from 'securing mechanism jammed' to 'knob jammed'.Functional inspection: it was observed that the knob which secures device onto the arm post was jammed.The knob was able to rotate as intended after the knob was lubricated and additional rotational force was applied.No visual abnormalities were found upon visual inspection.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.From lite decompression surgical technique: mount the arm post to the bed rail on the opposite side of surgeon near the patient¿s hip.Turn the arm post locking mechanism clockwise to secure it to the bed.Once secure, attach the snake arm to the arm post and lock into place.The snake arm should be positioned across the patient and wrapped in front of the surgeon.Note: the snake arm should be properly reset and lubricated between uses.Insert the handle of the tube into the clamp of the snake arm, and flip the clamp to secure.It is possible that the device was rotated prior to lubrication, which may have caused the device to jam.

• Brand Name: DECOMPRESSION TUBE SNAKE ARM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10438098
• Report Number: 0009617544-2020-00138
• Device Sequence Number: 19487571
• Product Code: LXH
• UDI-Device Identifier: 07613327263909
• UDI-Public: 07613327263909
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 11/13/2020

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: 48080230
• Device Catalogue Number: 48080230
• Device Lot Number: 18A738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• Initial Date Received by Manufacturer: 07/27/2020
• Supplement Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 08/21/2020
• Supplement Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1