MAUDE Adverse Event Report: AESCULAP AG FLEXIBLE SHAFT F/DRILL BITS; SPECIAL INSTRUMENTS FOR ACETAB

Model Number	NT419R
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/18/2023
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 flexible shaft f/drill bits (part # nt419r) was used during a procedure performed on an unspecified date.According to the complainant, the shaft broke while drilling bone.The shaft broke into two (2) pieces; one (1) piece remained attached to the drill, while the other detached into the patient.The separated section was removed from the patient with the drill bit intact.The flexible shaft was the only part that was broken.No backup device was available, so the physician proceeded a backup device was not available, so the surgeon had to push really hard until he got a bite in the bone which allowed the screw to self-tap into the bone.Reportedly, the device was being used as intended.Although the doctor may have been a little rough with it, no other occurrences were observed during the approximate twenty (20) to thirty (30) prior cases where this device was used.Although an additional medical intervention was necessary, no patient complications were reported as a result of this event.The adverse event is filed under aic reference (b)(4).
Event or Problem Description
Investigation complete.
Additional Manufacturer Narrative
Investigation results: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.Batch history review: the device history records (dhr) were not able to be reviewed as no lot number was made available.However, all device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.Conclusion and measures / preventative measures: a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• Brand Name: FLEXIBLE SHAFT F/DRILL BITS
• Common Device Name: SPECIAL INSTRUMENTS FOR ACETAB
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 17077790
• Report Number: 2916714-2023-00066
• Device Sequence Number: 19395838
• Product Code: FQP
• UDI-Device Identifier: 04046964093487
• UDI-Public: 4046964093487
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2023
• Report Date (Section F): 06/07/2023

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: NT419R
• Device Catalogue Number: NT419R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/18/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/18/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 06/30/2023
• 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: 06/07/2023