MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PRECISION THIN (9.0 X 0.38 X 31.0MM); BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	2296003125
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported that during a hto procedure, two blades broke at the mount.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 first blade that broke.
Additional Manufacturer Narrative
H6: the quality investigation is complete.
Event or Problem Description
It was reported that during a hto procedure, two blades broke at the mount.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 first blade that broke.

• Brand Name: PRECISION THIN (9.0 X 0.38 X 31.0MM)
• 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: 10844214
• Report Number: 0001811755-2020-03146
• Device Sequence Number: 3732793
• Product Code: GFA
• UDI-Device Identifier: 04546540046529
• UDI-Public: 04546540046529
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2020

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: 02/01/2025
• Device Model Number: 2296003125
• Device Catalogue Number: 2296003125
• Device Lot Number: 20057037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 12/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1