MAUDE Adverse Event Report: AESCULAP AG TC TENOTOMY SCISSDELCVD1/SERR130MM; DENTAL SCISSORS

Model Number DO250R

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/18/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: usa.Tips of tenotomy scissor broke off & hinge broke.Scissor broke while surgeon was using it.It ended up in 4 pieces.X-ray was negative, all pieces are accounted for.Type of surgery unknown at this time, enquiry has been made.No patient harm reported.No surgical delay reported.

Manufacturer Narrative

Investigation: the components have been examined visually and microscopically with a keyence vhx-5000 digital microscope and a panasonic dmc tz8 digital camera.Batch history review: the device quality and manufacturing history records have been checked for the available lot number.The device history file has been checked and found to be according to our specification valid at the time of production.No similar incidents have been filed with products from this batch.Conclusion and root cause: based on the information available as well as a result of our investigation, the root cause of the failure is most probably related to an insufficient maintenance of the device.Rational: the corrosion on the scissors is a so-called "stress corrosion", caused in combination with a mechanical tension.This type of corrosion often affects area or components that have been subjected to high tensile stress.This can be due to design limitations such as screw connections.Reprocessing of the instrument in a state of high tension (for example, closed blades during reprocessing) can speed up the defect.No capa is necessary.

• Brand Name: TC TENOTOMY SCISSDELCVD1/SERR130MM
• Type of Device: DENTAL SCISSORS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 6917885
• MDR Text Key: 89697682
• Report Number: 9610612-2017-00492
• Device Sequence Number: 1
• Product Code: EGN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/06/2018

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 Model Number: DO250R
• Device Catalogue Number: DO250R
• Device Lot Number: 1208530B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/29/2017
• Initial Date Manufacturer Received: 09/18/2017
• Initial Date FDA Received: 10/05/2017
• Supplement Dates Manufacturer Received: 09/18/2017
• Supplement Dates FDA Received: 03/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other