MAUDE Adverse Event Report: AESCULAP AG FINOCHIETTO RIB SPRDR ALUM 31X45 BLDS; CARDIO-THORACIC SURGERY

Model Number FC042A

Device Problems Mechanical Problem (1384); Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

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 product finochietto rib spreader.According to the complaint report "descriptoin" the gap of the aluminium retractor arm has been identified as a decontamination issue and can not be cleaned.In complaint report is noted that no injury has occurred.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: up to now, the product is not available for investigation.Batch history review: the traceability of articles without batch management requirement is guaranteed by the production order number, which can be traced over the production period and the corresponding customer.In addition, the raw materials, semi-finished parts, etc.Used for the order are documented in the manufacturing history records (dhr - device history records).This ensures the traceability of the internal supply and production chain.Internal traceability is thus guaranteed.Conclusion and root cause: without the product, an exact cause cannot be determined at this moment.Due to the constant monitoring of the compliance with our quality standards, as matters stand, a production or material defect can most likely be excluded.Therefore, the root cause of the error is most probably usage related.For further investigations, the product is required for examination.Rationale: to avoid damages to the product during reprocessing, the instructions of use must be observed a capa is not necessary.

• Brand Name: FINOCHIETTO RIB SPRDR ALUM 31X45 BLDS
• Type of Device: CARDIO-THORACIC SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9884812
• MDR Text Key: 186727206
• Report Number: 9610612-2020-00095
• Device Sequence Number: 1
• Product Code: GAD
• 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: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FC042A
• Device Catalogue Number: FC042A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1