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

Model Number	48080230
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the securing mechanism of the lite decompression tube snake arm would not capture the decompression tubes as the tip is crushed.The procedure was completed successfully with a 30 minute surgical delay.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Visual, functional, dimensional, and material analysis inspections could not be performed as the device was not returned.Device and complaint history records were not reviewed for this lot, as a valid lot number was not provided and could not be obtained.A review of complaint history associated with the subject catalog number was performed, and no adverse trends were observed.It was reported that during surgery the snake arm that connects to a decompression tube was not securing the tube properly and the distal lever/clamp allowing to retain the tube is deformed.The event resulted in 30 minuets surgical delay and no other patient harm.The ifu was reviewed and the following relevant text identified: the life of the instrument depends on the number of times they are used as well as the precautions taken in handling, cleaning and storage.Great care must be taken of the instruments to ensure that they remain in good working order.For instruments with articulations, lubrication may be necessary.Using a silicone lubricating cream is recommended.There is a text engraved on the tube "lubricate before use".The cause of the reported event cannot be determined conclusively without device evaluation.If device is returned, this complaint will be reopened and updated.H3 other text : status and location of the device is unknown.
Event or Problem Description
It was reported that the securing mechanism of the lite decompression tube snake arm would not capture the decompression tubes as the tip is crushed.The procedure was completed successfully with a 30 minute surgical delay.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
It was observed that the distal lever/clamp had deformed.The circular feature of the clamp had flattened.The device was functionally inspected using a sample decompression tube.The tube did not fit securely onto to clamp due to the deformation.The connection was unstable and the tube was moving.Device and complaint history records were reviewed for this lot, no relevant manufacturing issues or similar issues were identified.It was reported that during surgery the snake arm that connects to a decompression tube was not securing the tube properly and the distal lever/clamp allowing to retain the tube is deformed.The event resulted in 30 minuets surgical delay and no other patient harm.From the ifu: the life of the instrument depends on the number of times they are used as well as the precautions taken in handling, cleaning and storage.Great care must be taken of the instruments to ensure that they remain in good working order.For instruments with articulations, lubrication may be necessary.Using a silicone lubricating cream is recommended.There is a text engraved on the tube "lubricate before use".The most likely cause of the reported event is normal wear after repeated use.
Event or Problem Description
It was reported that the securing mechanism of the lite decompression tube snake arm would not capture the decompression tubes as the tip is crushed.The procedure was completed successfully with a 30 minute surgical delay.There were 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
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 12626672
• Report Number: 0009617544-2021-00200
• Device Sequence Number: 14539208
• Product Code: LXH
• UDI-Device Identifier: 07613327263909
• UDI-Public: 07613327263909
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 03/14/2022

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2021
• Supplement Date Received by Manufacturer: 01/05/2022; 02/18/2022
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 02/03/2022; 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown