MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3 11X340MM X 125; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 3525-1340S

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Injury (2348); Non-union Bone Fracture (2369); Implant Pain (4561)

Event Date 07/23/2020

Event Type  Injury  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

The nail broke.Revision had to be performed.

Manufacturer Narrative

The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.Device inspection revealed the following: the received nail is completely broken in the webs of the proximal lag screw hole.The appearance of the breakage surface of the posterior web suggests that the nail breakage had its origin in this area.Severe drill marks were found at the lateral entrance of the proximal through hole around the posterior web and the center; they progress through the bore towards medial.The drill marks were generated by a deviated lag screw step drill which most likely had created the starting point of the fracture (notching effect) at the lateral edge of the posterior web.The fracture pattern resembles a fatigue fracture, evident by very stark appearance of lines of rest/ waves.Starting from that region with an incipient crack at the lateral edge, the breakage progressed through the cross section.As a result of which the anterior web broke in a much quicker way with increased loading, in a slightly abrupt manner.The holes at the distal end of the nail also exhibit slight deformation, which is usually a sign of increased loading and screw movement.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The x-rays provided were presented to our hcp.However, the provided x-rays were not sufficient for a thorough evaluation, strictly based on the information available, the following comments were shared by the hcp: "in the one given ap plane: it looks as if the position of the nail is correct." "there seems to be a non-union, if there was no impact with a following breakage of the nail.The fracture line is subtrochanteric at a height with a high likelihood for the development of a bone healing problem." "considering patient¿s age.: [bone quality] cannot be assessed with confidence with only one x-ray given.However, the patient is very likely to have an osteopenic or osteoporotic bone and of course at that age the metabolism of the bone is slow as well.Therefore, there are some patient-related factors contributing to a potential delayed or non-union." "this is an ungrateful fracture localization combined with some patient related difficulties.¿ based on the above investigation, it can be said there is a strong likelihood of a non-union as stated by the hcp and given the patient¿s age.Also, there is an evident damage of the nail during its placement, hence the root cause of the breakage of the nail is attributed to a combination of user and patient related issues, but predominantly patient related.The op-tech states: ¿warning: in the event the nail is damaged during lag screw reaming, the fatigue strength of the implant may be reduced, which may cause nail to fracture.¿ the ifu states: ¿these devices can break when subjected to the increased loading associated with delayed unions and/or non-unions.Internal fixation devices are load sharing devices which are intended to hold fractured bone surfaces in apposition to facilitate healing.If healing is delayed or does not occur, the appliance may eventually break due to metal fatigue.Loads on the device produced by load bearing and the patient¿s activity level will dictate the longevity of the device.¿ if any further information is provided, the complaint report will be updated.

Event Description

The nail broke.Revision had to be performed.Additional information from the surgeon: "after 6 weeks of relief after implantation of the nail, mobilization was started.After initially good mobilization, increasing pain occurred in the operated hip up to immobilization.The fracture of the nail was then identified radiologically.There was a change to a cemented long-stem prosthesis.".

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3 11X340MM X 125
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 10427806
• MDR Text Key: 203720831
• Report Number: 0009610622-2020-00483
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07613252274278
• UDI-Public: 07613252274278
• Combination Product (y/n): N
• PMA/PMN Number: K034002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2024
• Device Model Number: 3525-1340S
• Device Catalogue Number: 35251340S
• Device Lot Number: K09262E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• Initial Date Manufacturer Received: 07/23/2020
• Initial Date FDA Received: 08/19/2020
• Supplement Dates Manufacturer Received: 09/17/2020
• Supplement Dates FDA Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 95 YR
• Patient Weight: 52