MAUDE Adverse Event Report: ZIMMER GMBH EXTRACTOR WITH SLIDING HAMMER

Model Number N/A

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

The manufacturer did not receive devices for review.Where lot numbers were received for the devices, the device history records were 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 an extractor with sliding hammer was used in a surgery.It was also reported: "the threads of the instrument broke up to the shaft in the lower third." no pieces were remaining in the patient.It was reported that the surgical technique was utilized.The surgery was completed with another instrument.The exact event date is unknown.

Manufacturer Narrative

Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: a trend has been identified.Two similar events (broken threads) for the same lot number have been reported.Due to the identified trend, further investigation has been performed (see below).Review of event description: it was reported that the thread was damaged in the lower third during surgery.Review of received data: on the photo received it is visible that the thread at the front part is damaged.Devices analysis visual examination: all 3 parts of the instrument were returned for investigation.It is visible that the thread at the front part is damaged.No other conspicuousnesses visible apart from usual signs of usage.Further investigation performed due to identified trend: analysis of extractor 01.06808.300: intended use: ¿the slothammer is used in conjunction with an extractor to remove a trial stem from the bone.It is moved up and down on the extractor to give an impulse to the extractor which will loosen the trial stem from the bone¿.The analysis of the design shows the following: ¿ two piece design of distal part: shaft and welded thread ¿ material of the shaft: 1.4021 (stainless martensitic steel) ¿ material of thread: 1.4435 (stainless austenitic steel) ¿the common thread length results in a range of 3.7 to 4.3mm.(ratio diameter m6 / contact length thread 3.7mm = 0.62) analysis of similar device 01.00109.801: intended use: ¿extractors are designed to remove a femoral stem or trial stem from the bone¿ the analysis of the design shows the following: ¿ one piece design ¿ material: 1.4021 (stainless martensitic steel) ¿ ratio common thread length: (ratio diameter m8 / contact length thread 5.8mm = 0.73) additional to the lot 4023558 which led to this investigation, two other lots which were manufactured on the same day led to complaints.In order to check if there is anything peculiar regarding products from this manufacturing date, the complained parts were retrieved and reviewed once more.The diameter and the length of the distal thread were checked with a calliper.The measured values showed that the instruments were correctly manufactured and according to drawing.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, the issue has been assessed as being systematic, due to a relatively high occurrence rate over the last ten years and due to the repeated error pattern.Root cause conclusion: based on the cause-effect/ fishbone analysis and a comparison of similar instruments , the most likely root cause for the failures of device 01.06808.300 is ¿design¿, especially: - the material used the thread is manufactured from austenitic stainless steel and not martensitic stainless steel.The material used cannot be hardened while martensitic stainless steel can be hardened, thus providing an increased resistance against wear.- the 2 piece design (additional interface and welding) although the design meets the specified requirement, design changes are expected to decrease the complaint rate for the breakage/deformation of the thread.No special issue regarding the present lot 4023558 could be identified according to the review of the design history records (dhr) within the complaint investigations.The design meets the specified functional requirements and the severity for a potential harm to patient or user has been evaluated as ¿minor¿ for an extended surgery time between 10 and 30 min.The issue could always be fixed with an alternative extraction instrument during surgery.Therefore, no containment actions were needed.An overview of the complaints history shows, that it is not unlikely to have two complaints within one lot, due to the relatively high numbers of complaints.As a corrective action, a design change has been initiated: align the design of extractor to 01.06808.300 to the design of the extractor 01.00109.801 with lower complaint rate: ¿ one piece design ¿ material change of thread from 1.4435 to 1.4021 (complete device manufacured from the same hardened martensitic stainless steel material).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: 6215329
• MDR Text Key: 63612829
• Report Number: 0009613350-2016-01512
• Device Sequence Number: 1
• Product Code: LZO
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2016

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: 4023558
• Other Device ID Number: 00889024288669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2016
• Initial Date FDA Received: 12/30/2016
• Supplement Dates Manufacturer Received: 08/14/2017
• Supplement Dates FDA Received: 08/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2014
• 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