MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO RECIPROCATING BLADE, DOUBLE SIDED, OFFSET (70.0 X 0.8 X 12.5MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Catalog Number 0277096276

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2018

Event Type  malfunction  

Manufacturer Narrative

The device is available for return.A follow up report will be filed once the quality investigation is complete.

Event Description

It was reported that four blades broke during a total knee procedure.It was also reported that there were no adverse consequences as a result of this event.It was further reported that there was a minor delay for the change out of blades and the procedure was completed.This report is for the second blade that broke.

Manufacturer Narrative

Investigation results indicate that the breakage could have been caused by the blade coming into contact with metal while cutting and/or also under the application of a bending moment while in use.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 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 associated devices ifu's state that the device and associated handpieces are "intended for use in the cutting, drilling, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures." the quality investigation is complete.

Event Description

It was reported that four blades broke during a total knee procedure.It was also reported that there were no adverse consequences as a result of this event.It was further reported that there was a minor delay for the change out of blades and the procedure was completed.This report is for the second blade that broke.

• Brand Name: RECIPROCATING BLADE, DOUBLE SIDED, OFFSET (70.0 X 0.8 X 12.5MM)
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8184314
• MDR Text Key: 131004500
• Report Number: 0001811755-2018-02852
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 04546540880673
• UDI-Public: 04546540880673
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2023
• Device Catalogue Number: 0277096276
• Device Lot Number: 18276017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Date Manufacturer Received: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1