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

Model Number FB800R

Device Problems Material Fragmentation (1261); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/06/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 282110922
• Report Number: 9610612-2021-00699
• Device Sequence Number: 1
• Product Code: GAD
• UDI-Device Identifier: 04038653157907
• UDI-Public: 4038653157907
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: FB800R-UNKNOWN
• Patient Outcome(s): Other