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

Lot Number 229868

Device Problems Break (1069); Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 11/18/2021

Event Type  malfunction  

Event Description

Tip of express sew needle broke off during case.Not seen on c-arm x-ray.Flat plate x-ray ordered.No evidence of missing foreign body within the intraoperative images.Provider felt that it likely was removed while irrigating the operative site.

• Brand Name: EXPRESSEW III
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY MITEK, LLC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 13009596
• MDR Text Key: 282270067
• Report Number: 13009596
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/10/2021

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 Operator: Health Professional
• Device Lot Number: 229868
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/10/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/15/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20075 DA
• Patient Sex: Female