MAUDE Adverse Event Report: AESCULAP AG COOLEY STERNOTOMY SPREADERADULT32X50MM; CARDIO-THORACIC SURGERY

Model Number FB850R

Device Problem Mechanical Jam (2983)

Patient Problem Insufficient Information (4580)

Event Date 11/05/2020

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 fb850r - cooley sternotomy spreaderadult32x50mm.According to the complaint description, during an open heart surgery on (b)(6) 2020 the cooley sternotomy spreaderadult32x50mm (a brand new device) was used and got stuck in a patient's chest.The device had to be forcibly removed from the chest during the procedure.The incident did not cause or contribute to a serious injury or to a patient death.An additional medical intervention was necessary.The device is available to be returned to the manufacturer for evaluation.Additional information was not provided nor available / was not available.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: vigilance investigator carried out the pictorial documentation visually and microscopically.The lever is fractured at the distal end, the analysis of the fracture patterns illustrated forced fractures due to overload.No pores, inclusions or foreign bodies could be found on the points of rupture.Friction marks can be found at the gliding planes, caused by insufficient lubrication.According to the instructions for use, the gliding planes must to be lubricated prior each use to void metal seizure.Additionally, "oil gliding planes before sterilization" is labelled at the device.Batch history review : the device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products found to be according to our specification valid at the time of production.Conclusion and measures / preventive: due to insufficient lubrication, metal seizure occurred and caused the jamming of the instrument.To avoid metal seizure, instructions for use must be observed.Du to the facts most probably root cause for the failure is reprocessing related.Based upon the investigations results there is capa is not necessary.

• Brand Name: COOLEY STERNOTOMY SPREADERADULT32X50MM
• Type of Device: CARDIO-THORACIC SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10930666
• MDR Text Key: 219182419
• Report Number: 9610612-2020-00853
• Device Sequence Number: 1
• Product Code: GAD
• UDI-Device Identifier: 04038653158218
• UDI-Public: 4038653158218
• Combination Product (y/n): N
• 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: 02/23/2021

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: FB850R
• Device Catalogue Number: FB850R
• Device Lot Number: 52419104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Initial Date Manufacturer Received: 11/05/2020
• Initial Date FDA Received: 12/01/2020
• Supplement Dates Manufacturer Received: 01/26/2021
• Supplement Dates FDA Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention