MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PRECISION THIN (7.0 X 0.38 X 18.5MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Catalog Number	2296003114
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/05/2018
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 surgical procedure, it was noted that the blade broke.It was further reported that all fragments of the blade were retrieved successfully.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 surgical procedure, it was noted that the blade broke.It was further reported that all fragments of the blade were retrieved successfully.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
Corrected data; the blade was initially reported to be a 2296-003-051 safedge precision thin (6.5 x 0.38 x 18.5mm).Upon product evaluation on 11-jan-2019, the catalog number of the blade received was identified as a 2296-003-114 precision thin (7.0 x 0.38 x 18.5mm).H6: investigation results indicate that a combination of excessive pressure on the blade from the handpiece caused the makings on the mount of the blade and metal contact along with bending and twisting while cutting could have caused the blade to break at the mount.The ifu of handpieces associated with this device warn the user against this type of use: "do not apply excessive pressure, such as bending or prying, with the cutting accessory.Excessive pressure may bend or fracture the blade and cause tissue damage and/or loss of tactile control." the associated devices ifu's state that the device and associated handpieces are "intended for surgical procedures involving cutting bone and hard tissue".The quality investigation is complete.

• Brand Name: PRECISION THIN (7.0 X 0.38 X 18.5MM)
• 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: 8130528
• Report Number: 0001811755-2018-02637
• Device Sequence Number: 19224772
• Product Code: GFA
• UDI-Device Identifier: 04546540046666
• UDI-Public: 04546540046666
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2019

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: 03/01/2023
• Device Catalogue Number: 2296003114
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Initial Date Received by Manufacturer: 11/08/2018
• Supplement Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 12/04/2018
• Supplement Report FDA Received Date: 01/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1