MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SILVERGLIDE BIPOLAR PRECISION FORCEPS BAYONET, 24CM / 0.7MM TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	6720240007
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/23/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The device guidestop screw had broken, posing the risk of a small component being lost in a surgical site, during sterile processing at the user facility.There were no adverse consequences related to this event.
Additional Manufacturer Narrative
Follow-up report submitted to document device evaluation results.User facility discarded the device.
Event or Problem Description
The device guidestop screw had broken, posing the risk of a small component being lost in a surgical site, during sterile processing at the user facility.There were no adverse consequences related to this event.

• Brand Name: SILVERGLIDE BIPOLAR PRECISION FORCEPS BAYONET, 24CM / 0.7MM TIP
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7789052
• Report Number: 0001811755-2018-01589
• Device Sequence Number: 16465627
• Product Code: GEI
• UDI-Device Identifier: 04546540532329
• UDI-Public: 04546540532329
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K992931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2018

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: Other
• Device Catalogue Number: 6720240007
• Device Lot Number: 266485
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 08/16/2018
• Supplement Report FDA Received Date: 11/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1