MAUDE Adverse Event Report: AESCULAP AG ABC DOUBLE DRILL GUIDE FIXED 14MM DEPTH; ABC SYSTEM INSTRUMENTS

Model Number	FJ834R
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to aesculap inc.That a abc double drill guide fixed 14mm depth (part # fj834r) was used during an anterior cervical procedure on november 1 2023.According to the complainant the device had broken during the procedure.Imaging was performed and determined that no fragments were inside the patient.The surgery was able to be successfully completed with a similar device.No patient complications were reported as a result of this event.The adverse event is filed under aic reference (b)(4).
Additional Manufacturer Narrative
Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Investigation results: a visual and microscopical investigation of the instrument and its fracture surfaces were made.At first, the fracture point at the instrument was investigated.Here was noted bad corrosion at the screw above the fracture surface, the fracture surface itself shows the typically signs of a forced fracture.In the next step, the fracture surface at the broken off leg was investigated.Even here the typical signs of a forced fracture and a corroded screw were found.Batch history review: the batch is unknown, but the instrument was in use for 23 years.Based on the customer's description of the error and the technical cause of this error, a batch reference can be ruled out.According to manufacturer's reporting evaluation in accordance with 21 cfr part 803, section 803.3, this event is considered reportable for the following reason - adverse event (not later than 30 days).The assessment for the reportability of this adverse event was based on the patient harm, additional medical intervention.Conclusion/preventive measures: the cause of the problem could not be conclusively clarified.Given the age of the instrument and the traces of corrosion that indicate certain deficiencies in the preparation, it can be assumed that the reason for this is wear.The investigation of the fracture surface shows no sign of a material error like inclusions of foreign material.

• Brand Name: ABC DOUBLE DRILL GUIDE FIXED 14MM DEPTH
• Common Device Name: ABC SYSTEM INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 18237052
• Report Number: 2916714-2023-00099
• Device Sequence Number: 15243773
• Product Code: LXH
• UDI-Device Identifier: 04038653253074
• UDI-Public: 4038653253074
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/12/2024
• Report Date (Section F): 11/30/2023

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: FJ834R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/02/2023
• Event Location: Hospital
• Date Report to Manufacturer: 11/02/2023
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 04/12/2024
• 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: 11/30/2023