MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PRECISION THIN (13.0 X 0.38 X 39.0MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Catalog Number	2296003108
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting confirmation if device is available.
Event or Problem Description
It was reported that during a commando procedure (combined mandibulectomy and neck dissection operation), two blades broke.It was also reported that there were no adverse consequences and no delays as a result of this event.It was further reported that the procedure was completed successfully.This report is for the second blade that broke.
Event or Problem Description
It was reported that during a commando procedure (combined mandibulectomy and neck dissection operation), two blades broke.It was also reported that there were no adverse consequences and no delays as a result of this event.It was further reported that the procedure was completed successfully.This report is for the second blade that broke.
Additional Manufacturer Narrative
H6: the device was not returned for investigation.The quality investigation is complete.H3 other text : device not returned.

• Brand Name: PRECISION THIN (13.0 X 0.38 X 39.0MM)
• 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: 9474792
• Report Number: 0001811755-2019-04053
• Device Sequence Number: 2660304
• Product Code: GFA
• UDI-Device Identifier: 04546540046482
• UDI-Public: 04546540046482
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 01/13/2020

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: 12/01/2022
• Device Catalogue Number: 2296003108
• Device Lot Number: 17345017
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 01/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1