MAUDE Adverse Event Report: ZIMMER GMBH Z NAIL CPM 10MMX21.5CM 130 L; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 01/03/2019

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive x-rays, or other source documents for review.Device history record (dhr) was reviewed and no discrepancies were found.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.(b)(4).

Event Description

It was reported that a implant fractured.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

Concomitant medical products: item# 47-2485-120-10, lot# 2939903, znn, cmn lag screw, 10.5 mm, 120 mm including set screw.Item# 47-2487-002-15, lot# 63656017, cephalomedullary nail cap 15 mm height.Item# 47-2493-000-00, lot# 4501789315, set screw, 8 mm, 21 mm, hex 3.5 mm.Item# unknown, lot# unknown, znn cmn screw trauma impl win gen.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: znn nail breakage.Event summary: it was reported that that there was an implant fracture.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received.Devices analysis: visual examination: the following components were received for product investigation: a znn nail, a lag screw, a nail cap, a set screw and a cortical screw.The set screw shows mechanical deformation at the tip, the pe part of the screw is partially deformed (possibly due to cleaning/sterilization) and it seems that the hexagonal part is damaged.The lag screw shows strong scratches on its body.Almost all 4 lag screw grooves are damaged.It cannot be said if the set screw was placed correctly in the groove of the lag screw.The cortical screw shows damage at the thread.The nail is fractured at the lag screw hole.There are some damages from revision surgery visible on the nail fragments.The fracture surface analysis shows a fatigue fracture pattern with beach marks.Based on this visual examination the reported event can be confirmed.Review of product documentation: all involved devices are intended for treatment.The compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.Surgical technique: the zimmer natural nail system cephalomedullary nail surgical technique describes the correct lag screw / set screw placement.The set screw should be tightened down into the groove in the lag screw.The lag screw inserter must be positioned so that the handle on the inserter is parallel or perpendicular to the colored dots on the targeting guide in order for the set screw and lag screw grooves to engage properly.To verify engagement, attempt to twist the lag screw inserter.If it cannot be rotated using a reasonable amount of force, the construct is in the correct position.If rotation is possible, adjust the position of the lag screw (rotate slightly) so that the set screw can enter correctly into the groove of the lag screw.Root cause analysis: root cause determination using rmw: breakage of implant due to inadequate design of mating components = not possible, as a systematic issue with design would have been detected as part of the issue evaluation assessment.Breakage of implant due to lack of adequate fatigue strength = not possible, as a systematic issue with design would have been detected as part of the issue evaluation assessment.Breakage of implant due to lack of adequate fatigue strength due to anodization = not possible, as a systematic issue with design would have been detected as part of the issue evaluation assessment.Breakage of implant due to incorrect distal nail design for short nails (flexible nail end) = not possible, as a systematic issue with design would have been detected as part of the issue evaluation assessment.Breakage of implant due to general corrosion (crevice, pitting, galvanic) = not possible, as the visual examination did not show any signs of corrosion.Breakage of implant due to the implant therapy is performed not as indicated =possible, as no surgical notes were received it is unknown how the implant therapy was performed.Therefore, this point cannot be excluded.Breakage of implant due to wrong interpretation of x-rays templates for dimensions lead to malreduction of the fracture = possible, as no x-rays were received, this point cannot be excluded.Breakage of implant due to users select wrong nail diameter,lenght and/or determine wrong ccd angle = possible, as no x-rays were received, this point cannot be excluded.Breakage of implant due to wrong/incomplete infomation about limitation and postoperative restrition = possible, as no surgical notes were available it is unknown which limitation was given to the patient.Therefore, this point cannot be excluded.Breakage of implant due to patient do not follow the post-operative protocol = possible, it is most possible that the patient did not follow the post op protocol.Breakage of implant due to explanted implant is used for new implantation surgery = possible, as no information was received that these are new products.Also no patient/product stickers were received.Conclusion summary: it was only reported that there was an implant fracture.The implantation and revision dates are unknown.It is also unknown how long the znn nail was implanted until the fracture was occurred.No x-rays, operative notes or office visit notes have been received for the investigation of the complaint.Patient factors that may affect the performance of the components such as bone quality, activity level, type of activity (low impact vs.High impact), and relevant medical history are unknown.Adherence to rehabilitation protocol is unknown.The product investigation showed that the returned components were heavily damaged.It can be also assumed that the deformations and damages were occurred during the removal procedure.The fracture surface analysis shows a fatigue fracture pattern with beach lines the visual examination of the nail indicates that no material defects that could have triggered the fracture could be detected.Based on the performed investigation, the root cause for the fracture of the nail cannot be determined with certainty.There are several factors which may have contributed to the nail breakage.It can be that the nail was over stressed during the in vivo time or a wrong patient behaviour can also be the cause for the breakage.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 previously reported event.

• Brand Name: Z NAIL CPM 10MMX21.5CM 130 L
• Type of Device: ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8361380
• MDR Text Key: 136853018
• Report Number: 0009613350-2019-00086
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00889024298958
• UDI-Public: 00889024298958
• Combination Product (y/n): N
• PMA/PMN Number: K091566
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 47-2493-213-10
• Device Lot Number: 2935201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention