MAUDE Adverse Event Report: DEPUY MITEK LLC US 8.5 X 55MM REUSABLE OBTURATOR -NS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 214117

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/06/2024

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.H10 additional narrative: h4: the device manufacture date is currently unavailable.Investigation summary the device associated with this report was returned to depuy synthes mitek for evaluation.Upon visual inspection revealed that the 8.5 x 55mm reusable obturator -ns shaft was detached from the handle.Worn marks were visible at the tip of the device.The overall complaint was confirmed as the observed condition of the 8.5 x 55mm reusable obturator -ns would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to the procedural variables, such handling of the device or product interaction during procedure.As per ifu; visually inspect the instrument and check for damage and wear, and it has been determined that no corrective and/or preventative action is required.As part of depuy synthes mitek quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.(b)(4).

Event Description

It was reported by the healthcare professional that during an unspecified surgical procedure, it was discovered that the stem pulled out of the handle of the 8.5 x 55mm reusable obturator device.During in-house engineering evaluation, it was determined that the shaft was detached from the handle (fell apart).It was reported that there were no delays in the surgical procedure and the surgery was completed successfully.It was not reported if a spare device was available for use.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: 8.5 X 55MM REUSABLE OBTURATOR -NS
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 18967508
• MDR Text Key: 338469833
• Report Number: 1221934-2024-00949
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886705003587
• UDI-Public: 10886705003587
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 214117
• Device Lot Number: 1706001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1