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

Model Number N/A

Device Problem Component or Accessory Incompatibility (2897)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.The device history records were reviewed and found to be conforming.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

The thread on the avenir extractor wasn't engaging with the thread on the avenir stem.Another extractor that was in consignment at the hospital was used.

Manufacturer Narrative

Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.No trend considering the following event is identified: damaged thread two additional similar investigated event within 6 months for item number have been found.Result: as two similar complaints of this device have been reported and triggered an ie due to lot trend, this complaint will also be included within the scope of the initiaed (b)(4).Event summary: an extractor with sliding hammer has been received.The thread on the instrument does not engage with the thread on the stem.Another extractor that was in the consignment was used.Surgery time extended for 5 minutes, but no risk to the patient.The damaged instrument wasn't used more than a couple of times before incident.Review of received data: no medical data such as surgical notes, patient data or history or any other case-relevant documents received.Devices analysis - visual examination: an extractor with sliding hammer has been received for investigation.The thread for engaging the stem was worn out.Further no considerable deteriorations, deformations or imperfections can be seen.Review of product documentation - compatibility: no compatibility check can be performed as only one product has been reported.- the manufacture day of lot no.4501563857 was before the the change project (closed on nov 30, 2017).Further, the purchase order confirmed that this batch was produced based on the old design.Root cause analysis the root cause analysis can be related to the capa, where the same damage mode was addressed.According to capa: based on the cause-effect/ fishbone analysis and a comparison of 2 similar instruments, the most likely root cause for the failures of the device 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 (b)(6) 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 of 0.61% no correction was performed regarding the products on the market, the instrument subject to this investigation is still of the old design as it was produced on (b)(6) 2017.Additionally, specific root cause determination has been performed using rmw: - instrument breaks, deforms, diverges impairing its function.Due to inadequate design for intended performance possible, as the damaged intrument is the old design before the change project, this cause cannot be excluded.However, as stated within the 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 intrument is the old design with previous material applicable before the 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 intriment 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 summary.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.However, as similar events have been reported, a capahas already been initiated and fully performed including the change project which was the outcome of the capa.During the change project the design and the material was changed.Despite of the performed changes, 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, so that the instrument subject to this investigation is still of the old design.According to the root cause analysis within capa 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

No change to initialy reported event.

• 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: 7771320
• MDR Text Key: 117007325
• Report Number: 0009613350-2018-00768
• 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: 11/08/2018

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: 4501563857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/12/2018
• Initial Date FDA Received: 08/10/2018
• Supplement Dates Manufacturer Received: 10/23/2018
• Supplement Dates FDA Received: 11/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1