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

Model Number	48080230
Medical Device Problem Codes	Mechanical Problem (1384); Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/02/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; surgeon noticed during surgery that snake arm is still mobile when fully tightened.
Additional Manufacturer Narrative
A visual inspection was performed and no visual non-conformances were identified.The returned device was confirmed to have its tightening knob jammed which was preventing the snake arm to get stiff enough to hold in place.The knob was lubricated and the instrument resumed its functionality.The plausible root cause of the event is determined to be lack of lubrication causing jamming.
Event or Problem Description
It was reported that; surgeon noticed during surgery that snake arm is still mobile when fully tightened.

• Brand Name: DECOMPRESSION TUBE SNAKE ARM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6827629
• Report Number: 0009617544-2017-00344
• Device Sequence Number: 1522696
• Product Code: LXH
• UDI-Device Identifier: 07613327263909
• UDI-Public: (01)07613327263909
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2017

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 Model Number: 48080230
• Device Catalogue Number: 48080230
• Device Lot Number: 108694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2017
• Initial Date Received by Manufacturer: 08/03/2017
• Supplement Date Received by Manufacturer: 08/03/2017
• Initial Report FDA Received Date: 08/29/2017
• Supplement Report FDA Received Date: 11/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1