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

Catalog Number	48080230
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/12/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the snake arm would not tighten as expected.The procedure was successfully completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
Method: visual inspection, functional inspection, product history review, complaint history review, nc/capa history review, labelling review, risk assessment result: the reported event of was confirmed via visual and functional inspection.The device was inspected and it was found that with the tube clamp opened and the clamp was flattened out.A test tube was installed onto the snake arm.The clamp and tube did not fit perfectly and there was loosening at the interface.The surgical technique states that "if repositioning of the tube is necessary, the tube can be wanded over the pathology using the dilators.The snake arm should be loosened before wanding.Once in the proper location, the arm assembly can be re-tightened.It is likely that the tip of the clamp flattened during the repositioning of the tubes.However according to the sales rep, the snake arm was loosened before wanding or repositioning the tube.Conclusion: the exact root cause could not be determined conclusively.
Event or Problem Description
It was reported that the snake arm would not tighten as expected.The procedure was successfully completed with no adverse consequences 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: 7771873
• Report Number: 0009617544-2018-00189
• Device Sequence Number: 1399676
• Product Code: LXH
• UDI-Device Identifier: 07613327263909
• UDI-Public: 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: Physician
• Type of Report: Initial,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: 48080230
• Device Lot Number: 176428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Initial Date Received by Manufacturer: 07/12/2018
• Supplement Date Received by Manufacturer: 10/29/2018
• Initial Report FDA Received Date: 08/10/2018
• Supplement Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1