MAUDE Adverse Event Report: AESCULAP AG STILLE BONE RONGEUR230MM; BONE RONGEURS AND BONE CUTTING

Model Number	FO530R
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2021
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.
Event or Problem Description
It was reported that there was an issue with fo530r-stille bone rongeur230mm as per information received via mw (b)(4).According to the complaint description, the rongeur broke during a total shoulder surgery.A screw broke in half and was recovered from operative wound.No retained foreign bodies on x-ray.An additional medical intervention was necessary.Additional information was not provided but has been requested.The adverse event / malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Additional information - d4 (lot #), d9, h4.Investigation: vigilance investigator carried out the pictorial documentation visually and microscopically.There are corrosion residues on the surface, most likely from reconditioning.The jaw cutting edge is damaged on both sides.The spring and one spring fixing screw are broken.The broken parts, except for one, are not available for examination.The remainder of the spring mounting screw is still in the threaded hole.This type of corrosion on the products is called a "stress corrosion" which occurs in conjunction with a mechanical stress and often affects areas or components subjected to high tensile stresses.This may be due to design limitations, such as threaded connections.Reprocessing the instrument under high tensile stress may accelerate the defect.Instruments with hairline cracks in the connection areas as well as instruments that are damaged, deformed or otherwise worn must be replaced as their function is no longer fully or sufficiently guaranteed.Batch history review: the device quality and manufacturing history records (dhr) 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.The review of risk assessment revealed that the overall risk level (severity 2(5) x probability of occurrence 1(5)) according to din en iso 14971 is still acceptable.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 on the investigation results, a capa is not required.

• Brand Name: STILLE BONE RONGEUR230MM
• Common Device Name: BONE RONGEURS AND BONE CUTTING
• 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: 11848740
• Report Number: 9610612-2021-00391
• Device Sequence Number: 3910717
• Product Code: HTX
• UDI-Device Identifier: 04038653047772
• UDI-Public: 4038653047772
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2022

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: FO530R
• Device Catalogue Number: FO530R
• Device Lot Number: 4507337852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2016
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male