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); Illegible Information (4050)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction

• 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 ; +1(908)386-3534
• MDR Report Key: 50550293
• Report Number: 1221934-2026-03915
• Device Sequence Number: 10384152
• Product Code: LXH
• UDI-Device Identifier: 10886705020218
• UDI-Public: (01)10886705020218(10)Incomplete
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Company Representative
• Type of Report: Initial,Followup

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: 8167726051409
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/28/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Supplement Date Received by Manufacturer: 09/29/2026
• Initial Report FDA Received Date: 09/01/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2026
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown