MAUDE Adverse Event Report: AESCULAP AG TC IRIS SCISSORS CVD S/S 110MM; DUROTIP SCISSORS

Model Number BC211R

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 02/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).When additional information is received a follow up report will be submitted.

Event Description

It was reported that the io tip had broken off.Using scissors for a carpal tunnel and tip broke off and stuck in tissue.Per the submission this incident did not cause serious injury or death but did cause a 5-10 min delay in surgery.The tip was removed manually from tissue.

Manufacturer Narrative

Investigation: the investigation was carried out visually and microscopically with a keyence vhx-5000 digital microscope and a panasonic dmc tz8 digital camera.We made a visual inspection of the instrument.Here we found an unknown labeling.Additionally, we detected dark staining at soldering points and material erosion at the soldering ponts.We made an optical inspection of the fracture surface.No abnormalities were found.Furthermore, we discovered unknown impurities.We also found a crack and visible damage.Batch history review: the device quality and manufacturing history records have been checked for the lot number and found to be according to the specification, valid at the time of production.No similar incidents have been filed with products from this batch.Conclusion and root cause: the root cause of the problem is most probably usage related.Rationale: according to the quality standard and dhr files, a material defect and production error can be excluded.No pores or inclusions could be found on the point of rupture.Investigations lead to the assumption that the breakage and crack were caused by an improper handling due to an overload situation.There is the possibility for pre-damage or similar due to previous surgeries.The dark staining and material erosion at the soldering points could be due to chemical and electrochemical influences in connection with an excessive acid content.No capa is necessary.

• Brand Name: TC IRIS SCISSORS CVD S/S 110MM
• Type of Device: DUROTIP SCISSORS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8371851
• MDR Text Key: 139339981
• Report Number: 9610612-2019-00103
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BC211R
• Device Catalogue Number: BC211R
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 03/22/2019
• Initial Date Manufacturer Received: 02/05/2019
• Initial Date FDA Received: 02/26/2019
• Supplement Dates Manufacturer Received: 03/22/2019
• Supplement Dates FDA Received: 03/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention