MAUDE Adverse Event Report: CAREFUSION, INC MAYO SUPERCUT D-EDGES SCISSORS CVD 6-3/4; SCISSORS, GENERAL, SURGICAL

Catalog Number 32-4820

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/31/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4) if further information becomes available a follow up medwatch will be submitted.

Event Description

The edge of the blade on the tip of the scissors broke/chipped off during use (mid-procedure while cutting fibrewire suture).The event date was (b)(6) 2018, cannot provide patient information due to (b)(6) privacy laws, no patient injury, the broken blade fell into the operative site and was retrieved with forceps, no x-ray or additional medical procedure was required, the event was resolved by replacing with another pair of scissors.The wrist repair was completed as planned.

Manufacturer Narrative

(b)(6).: mfr date: march 2003 a review of the mr.R log for 2003 was performed and no non-conformances were recorded for 32-4820, or its prefinished part numbers 78-0820 or 78-00830.No nonconformance were identified for the insert prefinished part numbers 44-0830 or 12-0689.A device history record for shop order (b)(4) was not available for review.Upon receipt the complaint sample received a visual examination.The following markings were found on the device: snowden pencer, usa, c03, ce, diamond edges supercut, and 4820.No evidence was found that the device was not authentic.As an investigation activity, the surface on the scissor forging that became exposed from the tungsten carbide blade separating from it was visually inspected, no evidence of voids in the brazing were identified to indicate a defect in the brazing process.The fracture in the tungsten carbide blade is perpendicular to the length of the blade.This suggests that the fracture may have occurred as the result of a lateral force as opposed to a shear force that would more likely cause a fracture line closer to parallel to the length of the blade.The tungsten carbide blades and the steel of the scissor forging have two different amounts of ductility and scissors have a feature called a crescent, which are slight opposing curves in the scissor halves that ensures that the cutting edges of the scissor always make contact as the scissor closes.This should not be confused with the non-opposing larger curve that is a feature of this curved scissor.As a result of the lateral forces on the tungsten carbide blade due to the crescent feature, as well as the dissimilar ductility between the tungsten carbide and the steel of the forging, a high enough number of open-close cycles (wear) may have caused the tungsten carbide to separate from the brazing joining it to the steel forging.This is not a defect, the crescent is how scissors prevent the media being cut from wedging between the blades, and the hardness of the tungsten carbide blade that makes it less ductile than the steel forging is the same reason the tungsten carbide blade has the longevity for sharpness that it does over scissors that are exclusively steel forged blades.The other possibility is that the blade was dull when the fracture occurred and because the blade was dull, a higher amount of force was required to perform cuts, and this excess force eventually sheared the tungsten carbide blade off of the steel forging.The complaint sample was found to not have the super cuts edge, indicating that the super cuts edge has either worn down completely, or the device was sharpened by a third-party repair company.Repair by snowden pencer would have resulted in an r1 etched on the device, which was not found on the device.The most probable root cause of the complaint failure mode was wear either from cyclical opening and closing, or from wearing the edge down dull.The portion of the tungsten carbide blade that broke off was not returned with the complaint sample to verify if the blade edge was dull or not and better determine a more precise root cause.It is also possible the scissors where not adequately sharpened by a third-party repair company.No defects were found in the brazing that joins the tungsten carbide blade to the steel forging and the dimensions at the tip of the device were found to be within specifications.Conclusion(s): the most probable root cause of the complaint failure mode was wear either from cyclical opening and closing over about 15 years, or from wearing the edge down dull.Half of one of the tungsten carbide blades was not returned with the complaint sample to verify if the blade edge was dull or not, to better determine a more precise root cause.It is also possible the scissors where not adequately sharpened by a third-party repair company.

Event Description

The edge of the blade on the tip of the scissors broke/chipped off during use (mid-procedure while cutting fibrewire suture).The event date was (b)(6) 2018, cannot provide patient information due to canadian privacy laws, no patient injury, the broken blade fell into the operative site and was retrieved with forceps, no x-ray or additional medical procedure was required, the event was resolved by replacing with another pair of scissors.The wrist repair was completed as planned.

Event Description

The edge of the blade on the tip of the scissors broke/chipped off during use (mid-procedure while cutting fibrewire suture).The event date was (b)(6) 2018, cannot provide patient information due to canadian privacy laws, no patient injury, the broken blade fell into the operative site and was retrieved with forceps, no x-ray or additional medical procedure was required, the event was resolved by replacing with another pair of scissors.The wrist repair was completed as planned.

Manufacturer Narrative

(b)(6): previously the device history for shop order was not available for review.However, it became available and this supplemental is being submitted.A review of the mrr log for 2003 was performed and no non-conformances were recorded for 32-4820, or its prefinished part numbers 78-0820 or 78-00830.No nonconformance were identified for the insert prefinished part numbers 44-0830 or 12-0689.The dhr for shop order (b)(4) was reviewed, all steps were initialed and dated as complete and no material substitutions were made.

• Brand Name: MAYO SUPERCUT D-EDGES SCISSORS CVD 6-3/4
• Type of Device: SCISSORS, GENERAL, SURGICAL
• Manufacturer (Section D): CAREFUSION, INC; 5 sunnen drive; st. louis MO 63143
• MDR Report Key: 7799407
• MDR Text Key: 117852047
• Report Number: 1923569-2018-00021
• Device Sequence Number: 1
• Product Code: LRW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/12/2018

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
• Device Catalogue Number: 32-4820
• Device Lot Number: C03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Initial Date Manufacturer Received: 08/03/2018
• Initial Date FDA Received: 08/20/2018
• Supplement Dates Manufacturer Received: 10/10/2018; 10/11/2018
• Supplement Dates FDA Received: 10/11/2018; 10/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other