MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PRECISION THIN (16.5 X 0.38 X 34.5MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Catalog Number	2296003104
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/13/2018
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 a mpfl (medial patellofemoral ligament reconstruction) surgical procedure, the blade broke.It was also reported that the broken fragment was noticed during x-ray and was removed from the patient.It was also reported that there were no adverse consequences and no delays as a result of this event.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
Investigation results indicate that a combination of excessive pressure, seen by the markings on the mount along with contact with metal surgical instruments, seen by the damage to the teeth, could have caused the blade to break at the mount.The ifu of handpieces associated with this blade warn the user against this type of use: "do not apply excessive pressure, such as bending or prying, with the blade.Excessive pressure may bend or fracture the blade and result in tissue damage, loss of tactile control, and/or the ejection of blade fragments at a high velocity".The quality investigation is complete.
Event or Problem Description
It was reported that during a mpfl (medial patellofemoral ligament reconstruction) surgical procedure, the blade broke.It was also reported that the broken fragment was noticed during x-ray and was removed from the patient.It was also reported that there were no adverse consequences and no delays as a result of this event.It was further reported that the procedure was completed successfully.

• Brand Name: PRECISION THIN (16.5 X 0.38 X 34.5MM)
• 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: 7757006
• Report Number: 0001811755-2018-01567
• Device Sequence Number: 1757460
• Product Code: GFA
• UDI-Device Identifier: 04546540046451
• UDI-Public: 04546540046451
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2018

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: No Information
• Device Expiration Date: 07/01/2022
• Device Catalogue Number: 2296003104
• Device Lot Number: 17184017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Initial Date Received by Manufacturer: 07/13/2018
• Supplement Date Received by Manufacturer: 08/24/2018
• Initial Report FDA Received Date: 08/07/2018
• Supplement Report FDA Received Date: 08/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1