MAUDE Adverse Event Report: AESCULAP AG FLEXIBLE SHAFT F/DRILL BITS; HIP ENDOPROSTHETICS

Model Number	NT419R
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 ag 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 / malfunction is filed under aag reference: (b)(4).
Additional Manufacturer Narrative
Additional information: d9 - no product return, e1 - reporter updated.Investigation: no investigation method could be applied, because: no product available.Therefore, an investigation of the product is not possible.Root cause cannot be finally concluded.Therefore the root cause specific risk cannot be identified.The potential risk determined during initial vigilance evaluation remains valid.Device history records: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Explanation and rationale: unfortunately, due to the lack of data and without the product, we cannot determine the exact cause of the mentioned deviation.According to the quality standard, a production defect and a material defect can be excluded with a high degree of probability.If further investigation is required, the product should be made available for examination.Preventive measures: based upon the investigation results, a capa is not necessary.

• Brand Name: FLEXIBLE SHAFT F/DRILL BITS
• Common Device Name: HIP ENDOPROSTHETICS
• 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: 17073628
• Report Number: 9610612-2023-00126
• Device Sequence Number: 20505359
• Product Code: HTW
• UDI-Device Identifier: 04046964093487
• UDI-Public: 4046964093487
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2023

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: NT419R
• Device Catalogue Number: NT419R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2023
• Supplement Date Received by Manufacturer: 06/23/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown