MAUDE Adverse Event Report: AESCULAP AG NOIR BABY-METZ SCISSORS CVD 145MM; DUROTIP SCISSORS

Model Number BC259B

Device Problem Material Fragmentation (1261)

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

Event Date 07/25/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with product noir baby-metz scissors cvd 145mm.During a unilateral orchidopexy the tip of the scissors broken off.X-ray images were taken to ensure that the broken tip did not remain in the patient's body.There was no more information available.The adverse event is filed under (b)(4).

Manufacturer Narrative

Manufacturing site evaluation: we received a complaint about one bc259b: noir baby-metz scissors cvd.The instrument arrived in a decontaminated condition and it is available for investigation.The broken off part is missing.During the intraoperative surgery the tip of the scissors broken.A x-ray for discard foreign body to the patient was necessary but the part wasn't found.Intra-operative medical intervention was necessary.Investigation: the investigation was carried out visually and microscopically with the digital microscope.We made a visual inspection of the instrument.Here we found visible damage and this is in an alignment with the fracture surface.Additionally we detected grooves.Furthermore we made an optical inspection of the fracture surface.Here we discovered discolorations and secondary damage but no anomalies were found.Batch history review: device quality and manufacturing history records have been checked for the lot number (4507294698) 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.Rationale: investigations lead to the assumption that the breakage was caused due to improper handling or the breakage was caused due to a stress-corrosion cracking.It appears that the dark discolorations are signs of an old crack.A pre-damage could have caused by a mechanical overload situation due to torsion or high leverage with the instrument.By an existing pre-damage or weak point, the reprocessing could be fracture-triggering.The secondary damages could have been caused due to movement of both parts each other after a crack.Due to the alignment of the fracture point and the visible damage, it appears that the breakage could have occurred during cutting.The grooves at the male box-lock could have caused due to an insufficient lubrication or foreign bodies.

• Brand Name: NOIR BABY-METZ SCISSORS CVD 145MM
• Type of Device: DUROTIP SCISSORS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8935741
• MDR Text Key: 155938020
• Report Number: 9610612-2019-00583
• 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: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BC259B
• Device Catalogue Number: BC259B
• Device Lot Number: 4507294698
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2019
• Date Manufacturer Received: 07/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 12 MO