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

Model Number	FB850R
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2020
Type of Reportable Event	Malfunction
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 spreader adult32x50mm.According to the complaint description, the device became stuck during use and was difficult to remove.The malfunction occurred during open heart surgery.There was no described patient harm nor delay in the procedure.Additional information was not provided but has been requested.The malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Additional information - block d9 investigation results, visual investigation: vigilance investigator carried out the pictorial documentation visually and microscopically.Friction marks and corrosion can be found at the gliding planes, caused by insufficient lubrication.Additionally, a modified surface structure can be found at the rack.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.
Event or Problem Description
The malfunction is filed under aag reference (b)(4).

• Brand Name: COOLEY STERNOTOMY SPREADERADULT32X50MM
• Common Device Name: SPECIALITIES CARDIO-THORACIC
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11030798
• Report Number: 9610612-2020-00944
• Device Sequence Number: 19030484
• Product Code: GAD
• UDI-Device Identifier: 04038653158218
• UDI-Public: 4038653158218
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FB850R
• Device Catalogue Number: FB850R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2020
• Supplement Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 06/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1