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

Model Number	FB850R
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem 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).
Additional 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
• Common Device Name: CARDIO-THORACIC SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10930666
• Report Number: 9610612-2020-00853
• Device Sequence Number: 19587906
• Product Code: GAD
• UDI-Device Identifier: 04038653158218
• UDI-Public: 4038653158218
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 11/05/2020
• Supplement Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 02/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention