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

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)
Date of Event	06/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Spd noticed that the suregrip tissue grasper 9" was missing the spike.
Additional Manufacturer Narrative
Innomed, inc.Was alerted of the described event via mail on june 28, 2022.No information was listed on the report regarding the initial reporter, or the user facility, therefore innomed was unable to request and receive the affected device to perform an evaluation.No investigation could be conducted.A survey of the internal complaints database identified that the described event also occurred with two similar parts (3645-01 and 3645-02).After an investigation was performed in each case, a root cause was determined and corrective and preventive measures were implemented.Innomed will continue to trend the affected and similar parts to determine if additional corrective and preventive measures are required.
Event or Problem Description
Spd noticed that "the" sure grip tissue grasper 9" was missing the spike.

• Brand Name: SUREGRIP SOFT TISSUE GRASPER 9"
• Common Device Name: PLIERS, PRODUCT CODE: HTC
• Manufacturer (Section D): INNOMED, INC.; 103 estus drive; savannah GA 31404
• Manufacturer (Section G): G. HIPP AND SOHN; carl benz strasse 1; d-78579; neuhausen ob eck, 78579 ; GM 78579
• Manufacturer Contact: irene davis ; 103 estus drive; savannah, GA 31404
• MDR Report Key: 14935174
• Report Number: 1833053-2022-00003
• Device Sequence Number: 14989429
• 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: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2022

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: 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/06/2022
• Supplement Report FDA Received Date: 08/30/2022
• 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
• Patient Sex: Unknown