MAUDE Adverse Event Report: ZIMMER GMBH EXTRACTOR WITH SLIDING HAMMER; N/A

Model Number N/A

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/09/2018

Event Type  malfunction  

Manufacturer Narrative

The manufacturer did not receive x-rays, or other source documents for review.The device history records were reviewed and found to be conforming.The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation.Additional information has been requested and is currently not available.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available, an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

It was reported that during a surgery the thread on the sliding hammer broke and the surgeon had to use a new kit to complete the case without delay.

Manufacturer Narrative

This follow-up report is being filled to relay investigation result.Dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: a trend considering the following event is identified: damaged thread one additional similar investigated events for the lot number 4501909558 have been found.The following complaints are considered: (b)(4).Result: trigger for an issue evaluation is met.However, an issue evaluation has already been initiated.Event description: event summary: an extractor with sliding hammer (ref: 01.06808.300 lot: 4501909558) has been received.The thread was torn after one use.Another tray was opened to finish the surgery.No impact to the patient and no surgery delay.Review of received data: no medical data such as surgical notes, patient data or history or any other case-relevant documents received.Device analysis: visual examination: an extractor with sliding hammer (ref: 01.06808.300 lot: 4501909558) has been received for investigation.Some scratches can been seen on the rod of the extension part.The thread was heavily stripped.Further no considerable deteriorations, deformations or imperfections can be seen on other parts of the instrument.Review of product documentation: compatibility: no compatibility check can be performed as only one product has been reported.The purchase order shows that this batch was produced based on the old design drawing revision.Root cause analysis: based on the cause-effect/ fishbone analysis and a comparison of 2 similar instruments (01.00109.801 and 01.06808.300), the most likely root cause for the failures of device 01.06808.300 is design, especially: the material 1.4435 (thread manufactured from austenitic and not martensitic stainless steel as e.G.1.4021.) material 1.4435 cannot be hardened while 1.4021 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.Therefore, change request was performed to address the issue.The change project has been fully performed and was closed on nov 30, 2017.Nevertheless, as the severity for a potential harm to the patient or user has been assessed to be minor and due to the low complaint rate no correction was performed regarding the products on the market, the instrument subject to this investigation is still of the old design as the purchase order was placed on 23.08.2017 with the old design drawing.Additionally, specific root cause determination has been performed using sap rmw: instrument breaks, deforms, diverges impairing its function.Due to inadequate design for intended performance: possible, as the damaged instrument is the old design before change project, this cause cannot be excluded.However, as stated within capa instruments of the old design can still be used.Instrument breaks, deforms, diverges impairing its function.Due to mechanical properties of material insufficient: possible, as the damaged instrument is the old design with previous material applicable before change project, this cause cannot be excluded.However, as stated within capa instruments of the old design can still be used.Damaged instruments, implants, body or wrong operational step due to surgeon or staff unfamiliar with instrument usage and handling: possible, as exceptionally high force could damage the thread due to wrong usage and handling.Instrument cannot be used with the mating instrument or mating implant as intended due to surgeon or staff unfamiliar with instrument usage and handling: possible, as the thread was damaged.This can be a consequence of unfamiliar with the instrument usage and handling.Damaged instruments, implants, body or wrong operational step due to surgeon or staff unfamiliar with instrument usage and handling: possible, as exceptionally high force could damage the thread due to wrong usage and handling.Instrument breaks or deforms due to off-label / abnormal-use: possible, as abnormal use could result in exceptionally high force or wrong force distribution which damages the thread.Fracture of instrument due to general corrosion (crevice, pitting, galvanic): not possible as no indication of corrosion was found on the damaged site.Conclusion: the damaged instrument has been returned for an investigation, based on the visual examination the complaint could be confirmed.The quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.Nevertheless, as the severity for a potential harm to the patient or user has been assessed to be minor and due to the low complaint rate no correction was performed regarding the products on the market, the instrument subject to this investigation is still of the old design.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; exceptionally high loads or loads in non-axial direction may 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.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

Please refer to report 0009613350-2018-00986.

• Brand Name: EXTRACTOR WITH SLIDING HAMMER
• Type of Device: N/A
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 7845165
• MDR Text Key: 119666076
• Report Number: 0009613350-2018-00986
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/27/2019

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: 4501909558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/13/2018
• Initial Date FDA Received: 09/05/2018
• Supplement Dates Manufacturer Received: 02/14/2019
• Supplement Dates FDA Received: 02/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1