MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 5 RECIP/STERNUM SAW; INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 4207000000

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 01/08/2014

Event Type  malfunction  

Event Description

It was reported that while testing the system 5 recip/sternum saw prior to a procedure, blades were being broken.There was no patient involvement and no adverse consequences associated with the device.

Manufacturer Narrative

The reported event, will not hold blade, and blade break, was duplicated; it was confirmed the handpiece would not hold blade and blades are being broken in running mode by the engineer at the technical service center in india through a functional inspection.A non-functioning drive train caused the device break blades while in run mode and to not holding the blade.The drive train was replaced and the handpiece was restored to normal function.

Event Description

It was reported that while testing the system 5 recip/sternum saw prior to a procedure, blades were being broken.There was no patient involvement and no adverse consequences associated with the device.

Manufacturer Narrative

Failure analysis is ongoing; additional information may be submitted once the results analysis is complete.

• Brand Name: SYSTEM 5 RECIP/STERNUM SAW
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 3595761
• MDR Text Key: 4339357
• Report Number: 0001811755-2014-00287
• Device Sequence Number: 1
• Product Code: KIJ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K972367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/08/2014

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
• Device Operator: Health Professional
• Device Catalogue Number: 4207000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2014
• Initial Date FDA Received: 01/28/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/10/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/27/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1