MAUDE Adverse Event Report: DEPUY MITEK LLC US EXPRESSEW; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	214140
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device had no physical damage when received, however; it did not function as expected.During in-house engineering evaluation it was determined that the lower jaw broke and detached.It was further determined that the upper jaw was detached from the shaft, also the pin actuator to jaw was detached.It was not reported if the device was used in a surgical procedure.There was no consequence or impact to the patient, and no signs, symptoms, or patient involvement were identified.The exact date of the event was not reported; however, it was reported that the event occurred in 2026.All available information has been disclosed.No further information was provided.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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 report, a follow-up report will be filed as appropriate.H11 additional narrative: investigation summary: the product and a photo were returned to depuy synthes for evaluation.Visual inspection of the returned photo found the lower jaw broken and detached.No other anomaly could be observed.Visual inspection of the returned device found that the upper jaw was detached from the shaft, also the pin actuator to jaw was detached.The lower jaw was broken.No other anomalies were noted.A functional test was unable to be performed due to the post-manufacturing damage.The overall complaint was confirmed as the observed condition of the expressew iii w/o hook would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to the device might have been dropped or was tapped against a hard surface accidentally, as well as rough use could have contributed to the device observed condition.As per the instructions for use (ifu); inspect the device prior to use to ensure proper mechanical function.It has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes 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.

• Brand Name: EXPRESSEW
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 25029078
• Report Number: 1221934-2026-01746
• Device Sequence Number: 13295315
• Product Code: LXH
• UDI-Device Identifier: 10886705020218
• UDI-Public: (01)10886705020218(10)7990426022103
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 214140
• Device Lot Number: 7990426022103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2026
• 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
• Patient Sex: Unknown