MAUDE Adverse Event Report: ZIMMER GMBH EXTRACTOR WITH SLIDING HAMMER

Model Number N/A

Device Problems Device Operates Differently Than Expected (2913); Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 04/27/2016

Event Type  malfunction  

Manufacturer Narrative

The manufacturer did not receive the device or other source documents for review.Where lot numbers were received for the device, the device history records was reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).

Event Description

It was reported that the extractor could not be fixed to the implant.Further information was requested.

Manufacturer Narrative

Investigation results were made available.Device history records (dhr): ref: 01.06808.300, lot: 4023378.The device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend was identified.Review of event description: it was reported that the mounting thread was defective and that the impactor could not be fixed to the implant.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents were received.Devices analysis: visual examination: the thread is completely damaged and cannot be used anymore.Root cause determination using risk management worksheet: instrument breaks, deforms, diverges impairing its function due to inadequate design for intended performance: not possible: a design issue would have been detected during the trending procedure; instrument breaks, deforms, diverges impairing its function due to mechanical properties of material insufficient: not possible: a material issue would have been detected during the trending procedure.Inadequate usability of instrument due to inadequate design for intended handling performance: not possible: a design issue would have been detected during the trending procedure; instrument breaks or deforms due to off-label / abnormal-use: possible, the thread is completely damaged and the device cannot be used anymore.It is not described how the device was used; instrument cannot be used with the connected instrument as intended due to failure of instrument assembly condition: possible, the thread is completely damaged and the device cannot be used anymore.It is not described how the device was used.Conclusion summary: there are several conditions that might have contributed to this failure, e.G.: contaminated thread by foreign particles or substances can change the force distribution; loads in not only axial direction also change the load distribution on the thread; if the thread is not fully tightened, there is some clearance and not all thread turns are loaded.However, an exact root cause could not be determined.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.Zimmer's reference number of this file is (b)(4).

• Brand Name: EXTRACTOR WITH SLIDING HAMMER
• Type of Device: EXTRACTOR WITH SLIDING HAMMER
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; 1800 west center street; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 5672647
• MDR Text Key: 46039622
• Report Number: 0009613350-2016-00716
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/29/2016

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 Model Number: N/A
• Device Catalogue Number: 01.06808.300
• Device Lot Number: 4023378
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/29/2016
• Initial Date FDA Received: 05/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1