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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXSOMED CORPORATION INNATE INSTRUMENT KIT; PASSER, WIRE, ORTHOPEDIC
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EXSOMED CORPORATION INNATE INSTRUMENT KIT; PASSER, WIRE, ORTHOPEDIC Back to Search Results
Model Number EXINN914500
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/07/2023
Event Type  malfunction  
Event Description
Last case of doctor in operating room, a guide wire broke while drilling leaving a portion inside the patients hand (metacarpal).The portion was retrieved, aligned, and compared to similar guide wire.Wire matched the length.Portable x-ray was ordered for verification.X-ray was taken before suturing the surgical site.Image was sent to radiologist for reading and analysis.Doctors spoke over the phone and verified that there was no retained foreign body.Surgical site was completely closed and patient was transferred to pacu.
 
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Brand Name
INNATE INSTRUMENT KIT
Type of Device
PASSER, WIRE, ORTHOPEDIC
Manufacturer (Section D)
EXSOMED CORPORATION
135 columbia
suite 201
aliso viejo CA 92656
MDR Report Key17583534
MDR Text Key321528148
Report Number17583534
Device Sequence Number1
Product Code HXI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 07/17/2023
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 Model NumberEXINN914500
Device Catalogue NumberEXINN914500
Device Lot Number22304-01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/17/2023
Event Location Ambulatory Surgical Facility
Date Report to Manufacturer08/21/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/21/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age14965 DA
Patient SexFemale
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