MAUDE Adverse Event Report: ZIMMER INC SPINAL ROD CUTTER; HXZ

Catalog Number 00392500200

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Other device used: catalog #00392500200, spinal rod cutter, lot #63180790.This report will be amended when our investigation is complete.

Event Description

It is reported that two spinal rod cutters were broken during surgery.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

Review of the device history record did not find any deviation or anomalies.Dimensions were found conforming to print specifications where measured.Visual inspection shows both products exhibit a fractured cutting surface.Scanning electron microscope fractography revealed that the tips of the bolt cutter samples were fractured due to overload.Predominantly the fracture surface exhibited ductile overload dimples both fractures.Suspected crack initiation and crack exit sites were identified on the fracture surfaces.No obvious inclusions and no fatigue fracture characteristics were identified on the samples' fracture surface.The package inserts included with these instruments state: "do not subject instruments to high loads and /or impact as breakage can occur".The package insert also states "the jaws of the rod cutter may fracture.When used on rods larger than 1/4 in.(6.4 mm) diameter; when the rod is cut using the tips of the jaws.Rods must be cut using the center of the jaws." not adhering to the stated instruction can cause fracture to the device.This device is used for treatment.

• Brand Name: SPINAL ROD CUTTER
• Type of Device: HXZ
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5250704
• MDR Text Key: 32250077
• Report Number: 1822565-2015-02479
• Device Sequence Number: 1
• Product Code: HXZ
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/02/2015

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: 00392500200
• Device Lot Number: 63180790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2015
• Initial Date FDA Received: 11/25/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/18/2015; 01/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1