MAUDE Adverse Event Report: AESCULAP AG TUFFIER RIB SPREADR170X12543X53MM BLDS; GENERAL SURGICAL INSTRUMENTS

Model Number	FB800R
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Foreign Body In Patient (2687)
Date of Event	08/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap inc.That a tuffier rib spreadr170x12543x53mm blds (part # fb800r) was used during an open thoracotomy with decortication left procedure on (b)(6) 2023.According to the complainant the device was difficult to open at first but was able to be utilized during the procedure.When the surgeon attempted to remove the device, it froze and would ot release or adjust.Reportedly the surgeon used a needle drive to attempt to open the insturment which caused the butterfly adjustment knob to break off.In order to remove the equipment the patient's rib was broken.Metal shavings were observed on the sterile towel that the instrument was placed on.Post operation chest radiography did not receal any metal shavings inside the patient.The surgery was able to be completed successfully.The adverse event is filed under aic reference (b)(4).
Event or Problem Description
Update: surgery was successfully completed.The patient did "well" after the procedure.Postoperative x-ray results had not revealed metal shaving.
Additional Manufacturer Narrative
Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.Additional information: b5 - update.D9 - product return.F9 - approximate age of device.Investigation results: visual inspection: the visual inspection of the products revealed a lot of damage to the products.The involved component (also same material) was found to have impact marks on the face of the wing gear and a large number of seizures.The leading material, tuffier chest retractor, also showed impact marks, seizure marks and a broken wing gear due to overload.Batch history review: as no lot number was provided, it is not possible to check the device history for the device in question.However, eight batches could be localized for the affected manufacturing year 2008: 51459722, 51465321, 51468332, 51484823, 51496201, 51507704, 51509918, 51513670.The device quality and manufacturing history records have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.Conclusion/preventive measures: on the basis of the available information as well as the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.According to the corresponding electronic instructions for use (eifu) (internal aesculap ag no.(b)(4) (b)(6) 2020 v6 change no.(b)(4)), a lack of/insufficient lubrication can lead to damage such as metallic cold welding/friction corrosion of the product.

• Brand Name: TUFFIER RIB SPREADR170X12543X53MM BLDS
• Common Device Name: GENERAL SURGICAL INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 18029615
• Report Number: 2916714-2023-00118
• Device Sequence Number: 20573493
• Product Code: GAD
• UDI-Device Identifier: 04038653157907
• UDI-Public: 4038653157907
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2024
• Report Date (Section F): 10/30/2023

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: FB800R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/04/2023
• Device Age: 16 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/04/2023
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 09/03/2024
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/30/2023