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

Catalog Number	48080230
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while turning the handle to tighten the snake arm, the arm locked up.This was noticed right before the patient entered the surgical room and another backup instrument was used to successfully complete the procedure.No adverse consequences were reported to the patient.
Additional Manufacturer Narrative
A visual inspection was performed, and no visual non-conformances were identified.A functional inspection was performed and the device could not be moved freely; however, upon lubrication, the arm moved freely.Dimensional inspection was not performed because there is no indication the event was related to dimensions of the device.Material analysis was not performed as there is no indication the event was related to the material properties of the device.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.It was reported the snake arm securing mechanism jammed pre-operatively.The cause of the reported issue was determined to be lack of lubrication.The surgical technique indicates ¿snake arm should be properly reset and lubricated between uses.¿.
Event or Problem Description
It was reported that while turning the handle to tighten the snake arm, the arm locked up.This was noticed right before the patient entered the surgical room and another backup instrument was used to successfully complete the procedure.No adverse consequences were reported to the patient.

• 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: 8409946
• Report Number: 0009617544-2019-00021
• Device Sequence Number: 13788355
• Product Code: LXH
• UDI-Device Identifier: 07613327263909
• UDI-Public: 07613327263909
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 06/25/2019

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: Health Professional
• Device Catalogue Number: 48080230
• Device Lot Number: 10E411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2019
• Initial Date Received by Manufacturer: 02/12/2019
• Supplement Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 03/11/2019
• Supplement Report FDA Received Date: 06/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1