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

Model Number 48080230

Device Problems Misconnection (1399); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2018

Event Type  malfunction  

Event 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.

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 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
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7298073
• MDR Text Key: 101155245
• Report Number: 0009617544-2018-00056
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07613327263909
• UDI-Public: (01)07613327263909
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1