MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP PRECISION OFFSET (5.5 X 0.51 X 18.0MM); BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL.

Model Number	2296033212
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The quality investigation is complete.
Event or Problem Description
It was reported that during an acl procedure the blade broke at the mount resulting in a delay of a few minutes.It was also reported that an x-ray was taken to ensure no broken pieces were left in the patient.It was further reported that there were no adverse consequences as a result of this event and the procedure was completed successfully.

• Brand Name: PRECISION OFFSET (5.5 X 0.51 X 18.0MM)
• 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: 11931302
• Report Number: 3015967359-2021-01038
• Device Sequence Number: 3831772
• Product Code: GFA
• UDI-Device Identifier: 04546540047007
• UDI-Public: 04546540047007
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Report Date (Section B): 06/03/2021

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: 2296033212
• Device Catalogue Number: 2296033212
• Device Lot Number: 20266027
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 06/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1