MAUDE Adverse Event Report: WENZLER GMBH CHROMA-LINE BLUE KERR RONG 8IN 2MM BITE; RONGEUR, MANUAL

Model Number NL4273-82

Device Problems Bent (1059); Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4) on 04jan2017, writer sent the customer an email acknowledging receipt of the complaint, providing the complaint tracking number and requested follow up information including as to if there was any patient impact related to this event.Writer provided contact information.Device not yet evaluated, if the device is evaluated a follow up will be sent.

Event Description

Customer reported via email: the kerrisons bent and broke during surgical cases.Patient impact unknown.On 04jan2016: additional information: what was the procedure that was being performed? yes.Did any part the instrument fall into the patient¿s body, and if so how was it retrieved? no.Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? x-ray performed with no instrumentation left in patient.What was the patient¿s outcome? no complications.Was the procedure completed as planned? yes.

Manufacturer Narrative

(b)(4).The samples were provided and an evaluation was performed.The instruments were manufactured in april and may of 2016.Instrument xwdz04 only has a bent baseplate.It is not broken.The instrument is no longer in the state in which it was delivered.Material has been removed, the tip has been grinded, the shifter has been shortened, and nominal dimension is 200 mm +0.5, measured: 198.87 mm.In order to compensate for the shortened slide, the main part and plug part have been modified.Sharp edges have been created and material has been removed.Now the moving part of the handle can push the slider further forward.The original specifications of the stopper are no longer present.Through the modifications to the instruments, the slider pushed the baseplate off by moving the handle.The base plate was reduced in the lower area (measured: 1.34 mm instead of 2 mm +/- 0.2 mm.The dished portion of the jaw has been thinned out.The coating was abraded on the inner surface.These modifications have a negative influence regarding load capacity during application.Instrument xdwz05 has the cutting edge bent upward at the slide, and again is not broken.The instrument is no longer in the state in which it was delivered.Material has been removed, the tip has been grinded, and a large amount of material has been removed at the distal end of the shifter tip, which made the edge area very thin.The damage to this instrument is typical when not used as intended, such as grasping wire.These modifications have a negative influence regarding load capacity during application.After failure and root cause analysis, it is clear that the failure happened because of an unauthorized 3rd party repair.There have been no issues identified with the material or manufacturing process.A review of the device history records (dhr) did not identify and issues that would have contributed to the reported issue.

• Brand Name: CHROMA-LINE BLUE KERR RONG 8IN 2MM BITE
• Type of Device: RONGEUR, MANUAL
• Manufacturer (Section D): WENZLER GMBH; steigäcker 22; balgheim 78582 ; GM 78582
• Manufacturer (Section G): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 north fairway drive; vernon hills, IL 60061
• MDR Report Key: 6236572
• MDR Text Key: 64276084
• Report Number: 1423507-2017-00079
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NL4273-82
• Device Lot Number: XWDZ-04, XWDZ-05
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2017
• Initial Date FDA Received: 01/10/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other