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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY ARMBOARD

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STERIS CORPORATION - MONTGOMERY ARMBOARD Back to Search Results
Device Problem Material Fragmentation (1261)
Patient Problem Laceration(s) (1946)
Event Type  malfunction  
Manufacturer Narrative
Steris became aware of this event on september 2, 2020 through our periodic review of the medsun database.The report did not identify the name or location of the user facility or the serial number of the device in question.To-date we have not been informed of this event directly from the user facility.We will fully investigate if the healthcare facility is identified at which point we will file a follow-up detailing the investigation.
 
Event Description
The user facility reported via user facility medsun report the following, "during a hand on demonstration of placing a surgical arm board on a surgical table a nursing students finger was injured when three metal shavings, each the size of a splinter, were embedded in the students hand.The metal shards were removed and the students finger was rinsed with alcohol and betadine.".
 
Manufacturer Narrative
The armboard subject of the event was returned for evaluation.Steris engineering inspected the armboard and found splintering on the carbon fiber matrix on the bottom of the armboard.The splintering was caused by excess pressure applied over time to that section of the armboard.The armboard instructions for use states: "warning - personal injury and/or equipment damage hazard: do not use equipment if worn, damaged or cannot be securely tightened.Cracked or splintered surfaces may cause injury.Inspect armboard prior to use.Damaged armboard must be replaced.Read and understand all instructions prior to use.If technical assistance or additional instructions are needed, call steris." a steris account manager performed in-service training on the proper use and operation of the armboard.No additional issues have been reported.
 
Manufacturer Narrative
Upon receipt of user facility medwatch report # 2301300000-2020-8020 on 9/10/2020, we reviewed our records and confirmed the event described in the user facility medwatch is the same event which was reported in mdr 1043572-2020-00037.A steris account manager is scheduling a visit with the customer to inspect the arm board.A follow-up mdr will be submitted when additional information becomes available.
 
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Brand Name
ARMBOARD
Type of Device
ARMBOARD
Manufacturer (Section D)
STERIS CORPORATION - MONTGOMERY
2720 gunter park drive east
montgomery, al
MDR Report Key10485077
MDR Text Key208961307
Report Number1043572-2020-00037
Device Sequence Number1
Product Code FQO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup,Followup
Report Date 09/02/2020
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
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 09/02/2020
Initial Date FDA Received09/02/2020
Supplement Dates Manufacturer Received09/02/2020
09/02/2020
Supplement Dates FDA Received10/08/2020
12/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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