MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP PRECISION (9.0 X 0.51 X 25.0MM); BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL.

Model Number	2296033111
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device discarded.
Event or Problem Description
It was reported that during a acl procedure, three blades broke.It was also reported that there were no delays as a result of this event.No additional information was provided.This report is for the first blade that broke.
Event or Problem Description
It was reported that during a acl procedure, three blades broke.It was also reported that there were no delays as a result of this event.No additional information was provided.This report is for the first blade that broke.
Additional Manufacturer Narrative
H6: the quality investigation is complete.

• Brand Name: PRECISION (9.0 X 0.51 X 25.0MM)
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL.
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• MDR Report Key: 11581372
• Report Number: 3015967359-2021-00287
• Device Sequence Number: 4182750
• Product Code: GFA
• UDI-Device Identifier: 04546540046956
• UDI-Public: 04546540046956
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2021

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: 09/01/2025
• Device Model Number: 2296033111
• Device Catalogue Number: 2296033111
• Device Lot Number: 20248017
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 03/29/2021
• Supplement Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1