MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO MICRO DUAL CUT (5.5 X 0.25 X 18.0MM); BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	5400003412
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting device return.
Event or Problem Description
It was reported that during a surgical procedure, the blade broke at the cutting end.No further information was provided.
Additional Manufacturer Narrative
B5: additional information provided on surgical procedure.H6 & d10: a photograph of the broken device was provided which confirmed the breakage.The definitive root cause could not be determined.The quality investigation is complete.
Event or Problem Description
It was reported that during a hallux valgus / scarf akin surgical procedure, the blade broke at the cutting end.No further information was provided.It was subsequently reported that there were no adverse consequences and no medical intervention as a result of this event.The was further reported that there was a procedural delay of two minutes.

• Brand Name: MICRO DUAL CUT (5.5 X 0.25 X 18.0MM)
• 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: 9284407
• Report Number: 0001811755-2019-03655
• Device Sequence Number: 1934646
• Product Code: GFA
• UDI-Device Identifier: 04546540401908
• UDI-Public: 04546540401908
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2020

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 Expiration Date: 04/01/2024
• Device Catalogue Number: 5400003412
• Device Lot Number: 19116027
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 01/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1