MAUDE Adverse Event Report: INNOMED, INC. SURE GRIP SOFT TISSUE GRASPER

Model Number	3645-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/08/2015
Type of Reportable Event	Malfunction
Event or Problem Description
The following description was received by the cdrh on (b)(6) 2017 with the assigned mdr report key 6259585: approximately 1mm part of a 3mm spike was gone at the end of surgery.Response: this event was initially received as a complaint on (b)(6) 2015.It is documented in innomed's internal complaints database.A thorough examination ensued, and a root cause was established.Corrective and preventive actions were implemented to fix the described issue, and prevent its recurrence.Containment activities were also performed.A copy of the investigative report was forwarded to the contact.The contact never responded.Medwatch form 3500a was received at innomed on jan.23rd with the same description as above.The initial reporter identified on the form was phoned and explained that innomed had previously received the same complaint from the same user facility regarding the same device and lot number.The complaint was addressed with the aforementioned actions and follow up activities were performed.The initial reporter at the time did not respond to the results of the investigation.The current initial importer relayed that a follow up response to the relayed information would be completed.

• Brand Name: SURE GRIP SOFT TISSUE GRASPER
• Common Device Name: TISSUE GRASPER
• Manufacturer (Section D): INNOMED, INC.; 103 estus drive; savannah GA 31404
• MDR Report Key: 6541381
• Report Number: 1833053-2017-00002
• Device Sequence Number: 864920
• Product Code: HWB
• UDI-Device Identifier: 00840277105943
• UDI-Public: 00840277105943
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/02/2017
• Report Date (Section F): 09/22/2015

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: Physician
• Device Model Number: 3645-02
• Device Catalogue Number: 3645-02
• Device Lot Number: 0512GH
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/23/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Date Report Sent to FDA: 09/22/2015