MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO THIN OFFSET W/8.0MM STOP (9.0 X 0.38 X 27.0MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Model Number	2296003528
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting device return.
Event or Problem Description
It was reported that during a blade broke during an anterior cruciate ligament surgical procedure.It was also reported that 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 blade broke during an anterior cruciate ligament surgical procedure.It was also reported that 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 product involved with this event was returned for evaluation and the reported failure of blade breakage was confirmed.The blade was evaluated by product engineering who concluded that based on the analysis performed on the blade, it is reasonable to suggest that blade fractures occurred due to the bending forces applied to the blade, evident from the heavy loading marks on the blade mounts, and / or the shock loading forces applied to the blade, evident from the damage sustained to the dead stop.The product instructions for use(ifu) for the handpeice for use with this blade 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".

• Brand Name: THIN OFFSET W/8.0MM STOP (9.0 X 0.38 X 27.0MM)
• 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: 9285980
• Report Number: 0001811755-2019-03664
• Device Sequence Number: 16181872
• Product Code: GFA
• UDI-Device Identifier: 04546540046710
• UDI-Public: 04546540046710
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 01/22/2020

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: 03/01/2024
• Device Model Number: 2296003528
• Device Catalogue Number: 2296003528
• Device Lot Number: 19070017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 01/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1