MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO L. MED AGGR BLADE (31MMX9MM)S; BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Model Number	2296003225
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/20/2020
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 an osteotomy surgery, the blade broke at the mount.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
The reported product involved with this event was returned for evaluation and the reported failure of blade breakage was confirmed.The bend / twist present in the blade suggests that it was subjected to an excessive bending force or torque.This bending force / torque is the most likely cause of the mount break.The shock loading caused by metal contact could have also contributed to the blade failure.The bending forces could have occurred by pushing the headpiece forward, pulling it backwards or twisting the headpiece while the end of the blade was engaged or held.The instruction for use (ifu) for the handpieces associated for use with this blade contain the following indication for use "when used with a variety of cutting accessories, the remb electric sagittal saw is intended for surgical procedures involving the cutting of bone and hard tissue." the ifu's also contain the following warning; "do not apply excessive pressure, such as bending or prying, with the blade.Excessive pressure may bend or fracture the blade and cause tissue damage and/or loss of tactile control.".
Event or Problem Description
It was reported that during an osteotomy surgery, the blade broke at the mount.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.

• Brand Name: L. MED AGGR BLADE (31MMX9MM)S
• 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: 9855820
• Report Number: 0001811755-2020-00714
• Device Sequence Number: 19485757
• Product Code: GFA
• UDI-Device Identifier: 04546540046550
• UDI-Public: 04546540046550
• 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: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2020

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 Model Number: 2296003225
• Device Catalogue Number: 2296003225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Initial Date Received by Manufacturer: 02/20/2020
• Supplement Date Received by Manufacturer: 04/10/2020
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 04/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1