MAUDE Adverse Event Report: AESCULAP AG FINOCHIETTO-BURFORD RIB SPREADRCOMPLETE; GENERAL SURGICAL INSTRUMENTS

Model Number	FB805R
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
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.Health effect - clinical code: no apprpriate term available: procedural complications.Adverse event was reported to manufacturer using medwatch report number (b)(4).
Event or Problem Description
It was reported to aesculap inc.That a finochietto-burford rib spreader (part # fb805r) was used during a thoracic surgery performed in (b)(6) 2020.According to the complainant, during the procedure, the surgeon was unable to open or close the chest retractor after it was placed inside the patient.Reportedly, the patient experienced a major bleed of the pulmonary artery, and because the device was not able to be opened, the surgeon was not able to fully access the bleed site to sew the wound.After approximately fifteen (15) minutes of struggling with the device, it was able to be freed and removed.The surgeon was then able to address the bleed and successfully complete the procedure.The complaint device was returned to the manufacturer for evaluation.Additionally, the device was noted as being approximately two (2) years old.The patient's condition was noted as being "fine" at the conclusion of the procedure.Additionally, the reporter confirmed that the patient was stable post operatively.The adverse event is filed under aag reference (b)(4).
Event or Problem Description
The adverse event is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation results: visual investigation: the instrument provided is in a used condition.Friction marks can be found at the gliding surfaces caused by insufficient reprocessing.Due to this damages, a proper function of the instruments are no longer given.To avoid metal-on-metal friction instructions for reprocessing must be observed.This is also labelled on the instrument directly.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.The review of risk assessment revealed that the overall risk level (severity 4(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results root cause was found to be insufficient reprocessing.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.

• Brand Name: FINOCHIETTO-BURFORD RIB SPREADRCOMPLETE
• Common Device Name: GENERAL SURGICAL INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11318037
• Report Number: 9610612-2021-00050
• Device Sequence Number: 4139999
• Product Code: GAD
• UDI-Device Identifier: 04038653157945
• UDI-Public: 4038653157945
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2022

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: FB805R
• Device Catalogue Number: FB805R
• Device Lot Number: 52477406_1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2021
• Supplement Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2200350000-2020-8007
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Race: White