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

Model Number	FB800R
Medical Device Problem Codes	Material Fragmentation (1261); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: 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 (b)(4) that a tuffier rib spreadr170x12543x53mm blds (part # fb800r) was used during a procedure performed on (b)(6) 2021.According to the complainant, the component of thumb screw, which controls the function of the blades opening and closing, was missing.The patient underwent an x-ray to confirm if part had detached at the surgical site.The surgery was delayed approximately twenty (20) minutes.The complaint device was returned to the manufacturer for evaluation.The adverse event / malfunction is filed under (b)(4).Involved component fb800r-tuffier rib spreadr170x12543x53mm blds.
Additional Manufacturer Narrative
Additional information - h4.Investigation results: visual inspection was performed.The instruments were forwarded to the manufacturing segment for examination.Excerpt from the report: "on the lobe screw, bv 439201 has broken off.This was soldered in and corresponded to the nominal at delivery.The solder connection is ideally evident at the point of breakage.On the production side, no defect can be detected." batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.The review of risk assessment revealed that the overall risk level (severity 1(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.Explanation and rationale: most likely, a mechanical overload due to incorrect preparation led to the breakage.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 investigation results a capa is not necessary.

• Brand Name: TUFFIER RIB SPREADR170X12543X53MM BLDS
• 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: 12724455
• Report Number: 9610612-2021-00699
• Device Sequence Number: 3855388
• Product Code: GAD
• UDI-Device Identifier: 04038653157907
• UDI-Public: 4038653157907
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2022

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: FB800R
• Device Catalogue Number: FB800R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2021
• Supplement Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 10/29/2021
• Supplement Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2017
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FB800R-UNKNOWN
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown