MAUDE Adverse Event Report: ALLEN MEDICAL SYSTEMS BOOT ASSEMBLY, TRACTION DEVICE,OT 1000; APPARATUS, TRACTION, NON-POWERED

Model Number	10009192
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report from a distributor noting it was found 2 non-serialized traction boots from same lot (23-268), where the boot base has been installed is facing the wrong direction.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).
Additional Manufacturer Narrative
Baxter received a report from a distributor noting it was found 2 non-serialized traction boots from same lot (23-268), where the boot base has been installed is facing the wrong direction.There was no patient/user injury reported.The traction boot is used for hip surgery.These devices are capable of being used with a broad patient population as determined appropriate by the caregiver or institution.The return of the product is still in process.No further information is available on the investigation of the device at this time.The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.
Event or Problem Description
Baxter received a report from a distributor noting it was found 2 non-serialized traction boots from same lot (23-268), where the boot base has been installed is facing the wrong direction.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).
Additional Manufacturer Narrative
A scar ((b)(6)) was issued to the supplier to investigate the issue and an ncr was generated (pr (b)(4)).The initial investigation by the supplier identified that the holding fixture used during manufacturing allows the material to be loaded upside down and the current quality inspection steps are not adequate to detect this defect.A new quality process was developed to detect that the parts passed "orientated so that the pin starts in the middle of the boot and points towards the rear" after the assembly is completed.In addition, the design of the 10009192 traction boots will be updated so that the pin assembly can only assembled in the correct orientation.A field action (fa-2024-009) was initiated to recall the involved devices of this nonconformance due to the risk of the device detaching from the traction system and resulting in patient harm and delay in surgery.The recalled devices will then be scrapped and have been replaced for the customer.Based on this information, no further action is required.

• Brand Name: BOOT ASSEMBLY, TRACTION DEVICE,OT 1000
• Common Device Name: APPARATUS, TRACTION, NON-POWERED
• Manufacturer (Section D): ALLEN MEDICAL SYSTEMS; 100 discovery way; acton MA 01720
• Manufacturer Contact: maritza valencia ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 18660886
• Report Number: 3010216206-2024-00003
• Device Sequence Number: 8063628
• Product Code: HST
• UDI-Device Identifier: 00615521000851
• UDI-Public: 615521000851
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2024

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
• Device Model Number: 10009192
• Device Lot Number: 23-268
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2024
• Supplement Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 02/07/2024
• Supplement Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown