MAUDE Adverse Event Report: ORTOMA AB OTS HIP; INSERTER ADAPTER OTD STRAIGHT

Model Number	1002
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer has reported a complaint regarding ref 30-201 inserter adapter otd straight.The issue was a weld breakage between the pin and inserter holder of inserter adapter otd straight during a surgical procedure.The adapters are intended to be used as a part of ots hip for real time tracking of instruments relative to the patient´s anatomy during orthopedic surgery.The inserter adapters are intended to be attached to a cup inserter tool.The weld breakage occurred while performing surgical impactions using johnson & johnson medtech emphasys straight impactor (the cup inserter tool), 4812-01-150.The surgical team noticed the breakage and the pin could be pulled out.To proceed with the surgery, the team started to use a second ref 30-201 inserter adapter otd straight (prepared as a back-up item, available in or).During the same surgical procedure, the second adapter failed during impactions, using the cup inserter tool.Also this failure consisted of a weld breakage between the pin and inserter holder.The surgical procedure could continue by reverting to conventional surgery.No injuries, medical intervention or prolonged hospitalization were reported.Images were provided together with the complaint.No adverse event occurred, however it is assessed as a malfunction.The malfunction would be weld breakage of the physical adapters.The weld which failed connects a pin to the adapter holder, the pin is intended to hold a tracer to be able to track the position of the instrument.A reoccuring device failure, either partial or complete weld breakage, if not detected by the user, could result in displaying incorrect information of the cup placement by ots¿ hip guide.This means that the values displayed on the screen do not correctly represent the actual angle and position of the tool.The potential harm to patients, if the surgeon relies on incorrect values, is dislocation or early loosening of implant.If the adapter weld breaks and another adapter is used, recalibration is needed, which may result in a slight delay of surgery (estimated to less than 3 minutes by hip surgeon).If the weld failure results in loose fragments or debris, there is a risk that these may fall into the surgical field.In case of weld failure during surgery, existing standard of care procedures and surgical techniques to mitigate any risk of fragments or debris entering the wound shall be taken.The weld may break during surgery due to high impact i.E.Force applied during e.G.Impaction or reaming.A complete weld failure is easily identifiable by user as the force applied during the surgery would cause the pin to fall off.A partial weld breakage that would impact the values displayed is identifiable by visual inspection of the weld and to verify that the pin is not loose.Per the instructions for use, inspection of the adapter is to be performed prior to and after surgery.

• Brand Name: OTS HIP
• Common Device Name: INSERTER ADAPTER OTD STRAIGHT
• Manufacturer (Section D): ORTOMA AB; falkenbergsgatan 3; gothenburg, västa götaland 412 8 5; SW 412 85
• Manufacturer (Section G): ORTOMA AB; falkenbergsgatan 3; gothenburg, västa götaland 412 8 5; SW 412 85
• Manufacturer Contact: fredrik hedberg ; falkenbergsgatan 3; gothenburg, västa götaland 412 8-5 ; SW 412 85
• MDR Report Key: 22613203
• Report Number: 3014411622-2025-00002
• Device Sequence Number: 5418854
• Product Code: OLO
• UDI-Device Identifier: 07350137521019
• UDI-Public: (01)07350137521019(10)20242009
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K232140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/25/2025

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: 1002
• Device Catalogue Number: 30-201
• Device Lot Number: 20242009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2024
• 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: Other
• Patient Sex: Unknown