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

Model Number	48080230
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Deformation Due to Compressive Stress (2889); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the securing mechanism of a lite decompression tube snake arm was unable to be locked intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully with a 30 minute surgical delay.
Event or Problem Description
It was reported that the securing mechanism of a lite decompression tube snake arm was unable to be locked intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully with a 30 minute surgical delay.
Additional Manufacturer Narrative
The device was not returned therefore inspection was not performed.Video of the reported failure was provided.Per the video, the distal lever/clamp is deformed.Specifically the circular feature of the clamp had flattened and it cannot fit securely on to the tube.The device is no longer functional.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.Complaint history records were reviewed for this catalog number, no adverse trends were identified.Per additional information received, the surgeon did not appear to use excessive force on the device, the device was part of a loaner set, and it is unknown how many times it has been used.From 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 root cause of the reported event cannot be determined conclusively.Factors that may have contributed to deformation are: normal wear after repeated use.Excessive force applied during previous procedures.H3 other text : device was discarded.

• 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: 13957336
• Report Number: 0009617544-2022-00038
• Device Sequence Number: 17364034
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2022

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/15/2022
• Supplement Date Received by Manufacturer: 06/17/2022
• Initial Report FDA Received Date: 03/30/2022
• Supplement Report FDA Received Date: 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown