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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SPINE-US DECOMPRESSION TUBE SNAKE ARM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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STRYKER SPINE-US DECOMPRESSION TUBE SNAKE ARM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Model Number 48080230
Device Problems Difficult or Delayed Positioning (1157); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/01/2021
Event Type  malfunction  
Event Description
It was reported that a lite decompression snake arm securing mechanism would not tighten intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.
 
Event Description
It was reported that a lite decompression snake arm securing mechanism would not tighten intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.
 
Manufacturer Narrative
Visual inspection: it was observed that the distal lever/clamp had deformed.The circular feature of the clamp had flattened.Functional inspection: 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, and no relevant manufacturing issues or similar complaints were identified.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".It was reported that tube was not lubricated and was used approximately dozen times while in sales rep possession (for approximately one year).The device has been used successfully previously.The most likely cause of the reported event is lack of lubrication and wear after repeated use.
 
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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 Key11366720
MDR Text Key233113977
Report Number0009617544-2021-00021
Device Sequence Number1
Product Code LXH
UDI-Device Identifier07613327263909
UDI-Public07613327263909
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 06/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number48080230
Device Catalogue Number48080230
Device Lot Number189325
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/09/2021
Date Manufacturer Received05/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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