MAUDE Adverse Event Report: AESCULAP AG TC BABY-METZ SCISSORSDELCVDB/B145MM; BASIC INSTRUMENTS

Model Number BC259R

Device Problem Break (1069)

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

Event Type  malfunction  

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 a baby metz scissor.During an orthopedic shoulder procedure, the scissor blade was broken.There was no patient harm.Additional information was not provided.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: the instrument arrived in a clean status with visible damage.The cemented carbide tips (b)(4) are cracked and loosened.Investigation was carried out microscopically.Here we found a cracked cemented carbide tip (b)(4) and visible damage.The device quality and manufacturing history records have been checked for the lot number (4510040148) and found to be according to the specification, valid at the time of production.Two similar incident have been filed with a product from the batch 4510040148 ((b)(4)).The root cause of the problem is most probably usage related.According to the quality standard and dhr files a material defect and production error can be excluded.Investigations lead to the assumption that the cracked cement carbide tip, cracked joint of the cement carbide tip and deformed scissor parts were caused due to improper handling by a mechanical overload situation.A capa was not initiated.

• Brand Name: TC BABY-METZ SCISSORSDELCVDB/B145MM
• Type of Device: BASIC INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8945524
• MDR Text Key: 156000574
• Report Number: 9610612-2019-00591
• 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: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BC259R
• Device Catalogue Number: BC259R
• Device Lot Number: 4510040148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Date Manufacturer Received: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1