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

Model Number	48080230
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the snake arm would not latch onto decompression tubes.There was a reported 15 minute delay.The procedure was successfully completed, and there were no reports of adverse consequences.
Additional Manufacturer Narrative
Method: visual inspection, functional inspection, device history review, complaint history review, risk assessment; result: the customer reported event was not confirmed as the device was functional during inspection.Product inspection upon return showed no deformation on the instruments.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Conclusion: since the device was found to the fully functional, the reported issue could not be confirmed.
Event or Problem Description
It was reported that the snake arm would not latch onto decompression tubes.There was a reported 15 minute delay.The procedure was successfully completed, and there were no reports of adverse consequences.

• 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: 7298073
• Report Number: 0009617544-2018-00056
• Device Sequence Number: 2274041
• Product Code: LXH
• UDI-Device Identifier: 07613327263909
• UDI-Public: (01)07613327263909
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 06/19/2018

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: Health Professional
• Device Model Number: 48080230
• Device Catalogue Number: 48080230
• Device Lot Number: 176428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Initial Date Received by Manufacturer: 02/01/2018
• Supplement Date Received by Manufacturer: 05/24/2018
• Initial Report FDA Received Date: 02/26/2018
• Supplement Report FDA Received Date: 06/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1