MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO MICRO DUAL CUT (9.0 X 0.38 X 25.0MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Model Number	5400003111
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device was discarded.
Event or Problem Description
It was reported that during an acl (anterior cruciate ligament) reconstruction surgery, two blades broke at the proximal end of the blade, no fragments remained at the surgical site.It was also reported that there were no adverse consequences as a result of this event.It was further reported that there was a five minute delay and the procedure was completed successfully.This report is for the second blade that broke.
Additional Manufacturer Narrative
H6: the quality investigation is complete.
Event or Problem Description
It was reported that during an acl (anterior cruciate ligament) reconstruction surgery, two blades broke at the proximal end of the blade, no fragments remained at the surgical site.It was also reported that there were no adverse consequences as a result of this event.It was further reported that there was a five minute delay and the procedure was completed successfully.This report is for the second blade that broke.

• Brand Name: MICRO DUAL CUT (9.0 X 0.38 X 25.0MM)
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10580211
• Report Number: 0001811755-2020-02459
• Device Sequence Number: 2822732
• Product Code: GFA
• UDI-Device Identifier: 04546540401816
• UDI-Public: 04546540401816
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 10/16/2020

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 Model Number: 5400003111
• Device Catalogue Number: 5400003111
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/26/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 10/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1