MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA HIP INSTRUMENTS; BAYONET DRILL BIT Ø3.2MM L45

Model Number	01.10.10.0845
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
While the surgeon was drilling to insert the screws into the cup, three different bayonet drill bits broke.The third broken drill got stuck in the patient (the smallest one).To retrieve it, the surgeon had to remove the cup and felt more secure in implanting a new one (same ref, different lot).The screws were successfully implanted with competitor drill bits.20-25 min delay reported.Patient's bone quality was hard/sclerotic.Drill guide was used (curved drill guide - golden tip, ref 01.10.10.372).
Additional Manufacturer Narrative
Batch review performed on 09 dec 2024 lot 2256825: (b)(4) items manufactured and released on 07-feb-2023.No anomalies found related to the problem.To date, no other similar events have been reported on the same lot during the period of review.Preliminary investigation performed by r&d project manager from the event description reported and from the images received we can see that all the three drill bits appears broken.Not all lots are known.Based on the information available, it is not possible to determine with certainty the root cause of reported breakage.Possible factors could be: a possible high level of flexion forces on the drill bits during their use, a possible friction with the shell and/or a very hard bone condition.Clinical evaluation performed by medical affairs department during the primary implantation of a total hip arthroplasty (tha), three bayonet drill bits broke during the drilling process for screw placement to achieve additional fixation of the cup.The broken drill bits were fully retrieved, ensuring no fragments remained in the patient.This is confirmed by the images available.In particular, the available x-ray image shows the final implanted prosthesis without evidence of foreign body, but provides no additional information regarding the cause of the instrument breakage.No secondary issues are anticipated for the patient as a result of this event.2 other drill bits were used and broke during the surgery, it is unknown which one got stuck into the patient's bone and the details of one drill bit is could not be identified.Details of the other drill bit: 01.26.10.0012 flexible bayonet drill ø 3.2 mm shaft l 56 lot.6344530001.
Additional Manufacturer Narrative
Details of the second other broken drill bit: hip general p8920 screw drill bit ø3.2 l35/20 lot.17h6729.Manufacturing process review: lot 17h6729 released: 15-may-2017, number of pieces released: (b)(4).All the steps, according to our routing sheet and relative drawings, have been performed correctly as well as the dimensional and functional controls.No other complaints received on this batch.There are no non-conformity elements in the document review.Visual inspection performed by r&d project manager from the event description reported and from the components received we can see that all the three drill bits are broken.Based on the information available and from the visual analysis of the components it is not possible to determine with certainty the root cause of reported breakage.Possible factors could be: an excessive torsional load and/or possible a high level of flexion forces on the drill bits during their use, a possible friction with the shell and/or a very hard bone condition.All components have worn and damaged cutting edges which may have caused the user to push/force the drill bit forward up to the point of breakage.Although no definitive root cause could be established, it is likely that a combination of factors contributed to the issue, such as excessive torsional load and/or possibly high levels of flexion forces on the drill bits during use, potential friction with the shell, and/or very hard bone condition.The investigation does not indicate any manufacturing-related issues or systemic deficiencies.

• Brand Name: HIP INSTRUMENTS
• Common Device Name: BAYONET DRILL BIT Ø3.2MM L45
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 21033592
• Report Number: 3005180920-2024-01088
• Device Sequence Number: 4070816
• Product Code: LXH
• UDI-Device Identifier: 07630971251700
• UDI-Public: 07630971251700
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 01.10.10.0845
• Device Lot Number: 2256825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Other
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 87 KG
• Patient Race: White