MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PERFORMANCE SERIES SAGITTAL BLADE (18.0X1.27X110.0MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Model Number	6118127110
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/18/2019
Type of Reportable Event	Serious Injury
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 total knee arthroplasty(tka) surgical procedure, the blade broke.It was also reported that the patient required additional surgery to remove the blade fragment.It was further reported that there were no adverse consequences as a result of this event and the procedure was completed successfully.
Additional Manufacturer Narrative
The blade reported involved in this event was returned for evaluation.On receipt of the blade the blade was observed to be broken at the both mount tabs where the blade locks into the handpiece.The blade was evaluated by product engineering who observed that heavy indentations were observed on both the top and bottom mount surfaces.Indentations like this would be caused by the mount of the blade impacting the retaining components of the handpiece.From the analyses outlined above, it¿s reasonable to suggest that the fractured mount tabs most likely occurred due to excessive movement between the blade and the retaining components of the handpiece.Movement (play) between the components will cause the blade to collide with the retaining components of the handpiece; causing a ¿hammering¿ effect that exposes the blade to shock loading forces.The larger the play, the higher the shock loading forces.Exposing the blade to shock loading forces will cause the indentations seen on the mount of the blade.It will also cause stress in the blades, cause cracks to form, and ultimately lead to fracture.As a result, the blade in this event is considered concomitant to the handpiece reported involved in this event.
Event or Problem Description
It was reported that during a total knee arthroplasty(tka) surgical procedure, the blade broke.It was also reported that the patient required additional surgery to remove the blade fragment.It was further reported that there were no adverse consequences as a result of this event and the procedure was completed successfully.

• Brand Name: PERFORMANCE SERIES SAGITTAL BLADE (18.0X1.27X110.0MM)
• 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: 9469016
• Report Number: 0001811755-2019-04048
• Device Sequence Number: 16708742
• Product Code: GFA
• UDI-Device Identifier: 04546540593382
• UDI-Public: 04546540593382
• 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): 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2024
• Device Model Number: 6118127110
• Device Catalogue Number: 6118127110
• Device Lot Number: 19124017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 02/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention