MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PERFORMANCE SERIES SAGITTAL BLADE (18.0X1.27X100MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Model Number	6118127100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device discarded by customer.
Event or Problem Description
It was reported that during a total knee arthroplasty(tka) surgery, the blade broke.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.
Event or Problem Description
It was reported that during a total knee athroplasty(tka) surgery, the blade broke.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
H6; the reported event, for blade breakage, was not confirmed as the blade was not returned for evaluation.Without the blade, the root cause cannot be determined.H3 other text : device discarded by customer.

• Brand Name: PERFORMANCE SERIES SAGITTAL BLADE (18.0X1.27X100MM)
• 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: 10373846
• Report Number: 0001811755-2020-02086
• Device Sequence Number: 14203625
• Product Code: GFA
• UDI-Device Identifier: 04546540501424
• UDI-Public: 04546540501424
• Combination Product (Y/N): N
• 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): 09/21/2020

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: 04/01/2025
• Device Model Number: 6118127100
• Device Catalogue Number: 6118127100
• Device Lot Number: 20111067
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/21/2020
• Supplement Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 09/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1