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

Model Number	232300
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During a left knee arthroscopy & acl repair the guidewire, approximately 6.5cm broke and remained in the patient's knee.This event was not discovered until the patient's first post operative appointment where an x-ray was completed and the foreign body was discovered.The patient was then rescheduled for a knee arthroscopy and foreign body removal.During the procedure, the patient tolerated the procedure well.The guidewire was removed without resistance.The surgeon stated that the patient did not have post operative complaints of pain outside of normal parameters of the patient's surgery.

• Brand Name: NA
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY MITEK, LLC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 13497386
• Report Number: 13497386
• Device Sequence Number: 11836175
• Product Code: LXH
• UDI-Device Identifier: 10886705011117
• UDI-Public: (01)10886705011117
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/17/2022
• Report Date (Section F): 01/17/2022

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 Model Number: 232300
• Device Catalogue Number: 232300
• Device Lot Number: 8L16832
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 02/09/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/09/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Date Report Sent to FDA: 01/17/2022