MAUDE Adverse Event Report: INNOMED, INC. SUREGRIP SOFT TISSUE GRASPER 9"; PLIERS

Model Number	3645-03
Medical Device Problem Code	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
After a case, the spike was noticed to be missing from the suregrip soft tissue grasper 9".Rad imaging ruled out rfb post case.

• Brand Name: SUREGRIP SOFT TISSUE GRASPER 9"
• Common Device Name: PLIERS
• Manufacturer (Section D): INNOMED, INC.; 103 estus drive; savannah GA 31404
• Manufacturer Contact: kai wissner ; carl benz strasse 1; neuhausen ob eck, 78579 ; GM 78579
• MDR Report Key: 14936774
• Report Number: 1833053-2022-00004
• Device Sequence Number: 4557449
• Product Code: HTC
• UDI-Device Identifier: 00840277105950
• UDI-Public: 00840277105950
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/06/2022

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
• Device Model Number: 3645-03
• Device Catalogue Number: 3645-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 07/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown