MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 23CM IM DISP BAYONET 0.5MM TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	6770230005
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during setup, a piece of the device was found to be broken off, posing the risk of material being lost in a surgical site.There was no patient involvement, no delay, no medical intervention, and no adverse consequences reported with this event.
Additional Manufacturer Narrative
H6: the quality investigation is complete.H3 other text : device not returned.
Event or Problem Description
The user facility reported that during setup, a piece of the device was found to be broken off, posing the risk of material being lost in a surgical site.There was no patient involvement, no delay, no medical intervention, and no adverse consequences reported with this event.

• Brand Name: 23CM IM DISP BAYONET 0.5MM TIP
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9527161
• Report Number: 0001811755-2019-04176
• Device Sequence Number: 16246140
• Product Code: GEI
• UDI-Device Identifier: 37613327300162
• UDI-Public: 37613327300162
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K110924
• 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): 05/11/2020

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 Catalogue Number: 6770230005
• Device Lot Number: 19071
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 05/08/2020
• Initial Report FDA Received Date: 12/27/2019
• Supplement Report FDA Received Date: 05/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1