MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY ARMBOARD

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.

• Brand Name: ARMBOARD
• Type of Device: ARMBOARD
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery, al
• MDR Report Key: 10485077
• MDR Text Key: 208961307
• Report Number: 1043572-2020-00037
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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 Received: 09/02/2020
• Supplement Dates Manufacturer Received: 09/02/2020; 09/02/2020
• Supplement Dates FDA Received: 10/08/2020; 12/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1