MAUDE Adverse Event Report: ORTHOFIX SRL SLOTTED MALLET ADAPTOR

Catalog Number	177385
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device involved in this event has not been returned for investigation, but it has been requested to return.If the device is returned an investigation will be completed and a follow up report will be submitted.
Event or Problem Description
As per the reporter, they experienced a breakage of the mallet adaptor during the surgical procedure causing a surgical delay of one hour.No patient harm was reported.
Event or Problem Description
As per the reporter, they experienced a breakage of the mallet adaptor during the surgical procedure causing a surgical delay of one hour.No patient harm was reported.
Additional Manufacturer Narrative
A visual analysis was performed on the returned mallet adaptor (code 177385) and alleged event was confirmed.Additional surface marks were also observed on the distal area of the component.The fractured surface appeared relatively uniform, with no visible evidence of bending and plastic deformation.The macroscopic examination did not reveal signs of significant ductile behavior, and the observed characteristics are consistent with a brittle-type failure mode.The affected adaptor is a multiple-use device manufactured in 2022.According to the device's intended use and the operative instructions described in the operative technique, ah-2001-opt, the adaptor can be used in conjunction with the slotted mallet during the nail insertion phase, ensuring that hammering is applied exclusively on the designated striking interfaces.Applying impact or force to areas of the targeting assembly that are not designed to receive direct loading may lead to damage.

• Brand Name: SLOTTED MALLET ADAPTOR
• Common Device Name: SLOTTED MALLET ADAPTOR
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• Manufacturer (Section G): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• Manufacturer Contact: elvira taccarelli ; via delle nazioni, 9; bussolengo, verona 37012 ; IT 37012
• MDR Report Key: 23449231
• Report Number: 9680825-2025-00042
• Device Sequence Number: 15705371
• Product Code: HSB
• UDI-Device Identifier: 18033509858956
• UDI-Public: 18033509858956
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K141571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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 Catalogue Number: 177385
• Device Lot Number: AL1811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Female